{
  "build": {
    "pulled_at": "2026-10-29T15:49:33.967Z",
    "pull_date": "2026-10-29",
    "source": "https://api.fda.gov/device/510k.json",
    "openfda_last_updated": "2026-10-19",
    "date_range": {
      "start": "2021-01-01",
      "end": "2026-10-29"
    },
    "raw_record_count": 18603,
    "openfda_reported_total": 18603,
    "pagination_truncated": false,
    "clean_record_count": 18404,
    "dropped": {
      "not_510k_denovo": 199,
      "missing_dates": 0,
      "negative_span": 0,
      "implausible_span": 0
    },
    "method_notes": [
      "Source endpoint also returns De Novo grants (k_number prefix \"DEN\"); these are excluded — this dataset covers 510(k)s only (k_number prefix \"K\").",
      "review_days = decision_date minus date_received, in calendar days (FDA calendar days from receipt to decision — includes sponsor hold time; not a measure of FDA review clock days).",
      "Records with missing dates, a negative span, or a span over 1500 days are excluded.",
      "Decision year is the calendar year of decision_date (UTC).",
      "\"Latest full year\" = 2025. Current year-to-date = 2026 through 2026-10-29.",
      "Refresh cadence: quarterly, by re-running this script (clears/extends the cache as needed)."
    ]
  },
  "by_year": [
    {
      "year": 2021,
      "label": "2021",
      "count": 2993,
      "median_days": 135,
      "mean_days": 168.6,
      "p75_days": 231,
      "p90_days": 340
    },
    {
      "year": 2022,
      "label": "2022",
      "count": 3187,
      "median_days": 143,
      "mean_days": 185,
      "p75_days": 256,
      "p90_days": 396
    },
    {
      "year": 2023,
      "label": "2023",
      "count": 3299,
      "median_days": 135,
      "mean_days": 176.3,
      "p75_days": 245,
      "p90_days": 358
    },
    {
      "year": 2024,
      "label": "2024",
      "count": 3082,
      "median_days": 129,
      "mean_days": 158.6,
      "p75_days": 228,
      "p90_days": 270
    },
    {
      "year": 2025,
      "label": "2025",
      "count": 3198,
      "median_days": 126,
      "mean_days": 146.1,
      "p75_days": 213,
      "p90_days": 267
    },
    {
      "year": 2026,
      "label": "2026 (YTD through 2026-10-29)",
      "count": 2645,
      "median_days": 132,
      "mean_days": 152.1,
      "p75_days": 230,
      "p90_days": 268
    }
  ],
  "by_panel": {
    "latest_full_year": 2025,
    "rows": [
      {
        "panel_code": "RA",
        "panel_name": "Radiology",
        "count": 478,
        "median_days": 144.5,
        "p90_days": 265
      },
      {
        "panel_code": "OR",
        "panel_name": "Orthopedic",
        "count": 404,
        "median_days": 87,
        "p90_days": 260
      },
      {
        "panel_code": "SU",
        "panel_name": "General, Plastic Surgery",
        "count": 379,
        "median_days": 91,
        "p90_days": 258
      },
      {
        "panel_code": "CV",
        "panel_name": "Cardiovascular",
        "count": 349,
        "median_days": 132,
        "p90_days": 268
      },
      {
        "panel_code": "GU",
        "panel_name": "Gastroenterology, Urology",
        "count": 258,
        "median_days": 137.5,
        "p90_days": 266
      },
      {
        "panel_code": "DE",
        "panel_name": "Dental",
        "count": 228,
        "median_days": 116,
        "p90_days": 271
      },
      {
        "panel_code": "NE",
        "panel_name": "Neurology",
        "count": 218,
        "median_days": 126,
        "p90_days": 267
      },
      {
        "panel_code": "HO",
        "panel_name": "General Hospital",
        "count": 188,
        "median_days": 121,
        "p90_days": 267
      },
      {
        "panel_code": "MI",
        "panel_name": "Microbiology",
        "count": 120,
        "median_days": 153,
        "p90_days": 268
      },
      {
        "panel_code": "PM",
        "panel_name": "Physical Medicine",
        "count": 111,
        "median_days": 111,
        "p90_days": 268
      },
      {
        "panel_code": "AN",
        "panel_name": "Anesthesiology",
        "count": 99,
        "median_days": 189,
        "p90_days": 272
      },
      {
        "panel_code": "OB",
        "panel_name": "Obstetrics/Gynecology",
        "count": 93,
        "median_days": 154,
        "p90_days": 267
      },
      {
        "panel_code": "UN",
        "panel_name": "Unknown",
        "count": 63,
        "median_days": 140,
        "p90_days": 273
      },
      {
        "panel_code": "CH",
        "panel_name": "Clinical Chemistry",
        "count": 53,
        "median_days": 158,
        "p90_days": 269
      },
      {
        "panel_code": "EN",
        "panel_name": "Ear, Nose, Throat",
        "count": 44,
        "median_days": 163.5,
        "p90_days": 266
      },
      {
        "panel_code": "OP",
        "panel_name": "Ophthalmic",
        "count": 38,
        "median_days": 157.5,
        "p90_days": 281
      },
      {
        "panel_code": "HE",
        "panel_name": "Hematology",
        "count": 22,
        "median_days": 97,
        "p90_days": 270
      },
      {
        "panel_code": "TX",
        "panel_name": "Clinical Toxicology",
        "count": 21,
        "median_days": 50,
        "p90_days": 265
      },
      {
        "panel_code": "IM",
        "panel_name": "Immunology",
        "count": 19,
        "median_days": 231,
        "p90_days": 268
      },
      {
        "panel_code": "PA",
        "panel_name": "Pathology",
        "count": 13,
        "median_days": 239,
        "p90_days": 397
      }
    ],
    "current_year_to_date": 2026,
    "rows_ytd": [
      {
        "panel_code": "RA",
        "panel_name": "Radiology",
        "count": 390,
        "median_days": 132.5,
        "p90_days": 260
      },
      {
        "panel_code": "OR",
        "panel_name": "Orthopedic",
        "count": 357,
        "median_days": 96,
        "p90_days": 263
      },
      {
        "panel_code": "CV",
        "panel_name": "Cardiovascular",
        "count": 342,
        "median_days": 144,
        "p90_days": 271
      },
      {
        "panel_code": "SU",
        "panel_name": "General, Plastic Surgery",
        "count": 280,
        "median_days": 105,
        "p90_days": 264
      },
      {
        "panel_code": "GU",
        "panel_name": "Gastroenterology, Urology",
        "count": 199,
        "median_days": 137,
        "p90_days": 269
      },
      {
        "panel_code": "DE",
        "panel_name": "Dental",
        "count": 178,
        "median_days": 111.5,
        "p90_days": 269
      },
      {
        "panel_code": "NE",
        "panel_name": "Neurology",
        "count": 164,
        "median_days": 128,
        "p90_days": 266
      },
      {
        "panel_code": "HO",
        "panel_name": "General Hospital",
        "count": 117,
        "median_days": 182,
        "p90_days": 273
      },
      {
        "panel_code": "PM",
        "panel_name": "Physical Medicine",
        "count": 114,
        "median_days": 119.5,
        "p90_days": 252
      },
      {
        "panel_code": "OB",
        "panel_name": "Obstetrics/Gynecology",
        "count": 87,
        "median_days": 160,
        "p90_days": 270
      },
      {
        "panel_code": "UN",
        "panel_name": "Unknown",
        "count": 78,
        "median_days": 169,
        "p90_days": 269
      },
      {
        "panel_code": "AN",
        "panel_name": "Anesthesiology",
        "count": 76,
        "median_days": 249,
        "p90_days": 321
      },
      {
        "panel_code": "MI",
        "panel_name": "Microbiology",
        "count": 75,
        "median_days": 111,
        "p90_days": 252
      },
      {
        "panel_code": "CH",
        "panel_name": "Clinical Chemistry",
        "count": 56,
        "median_days": 159,
        "p90_days": 270
      },
      {
        "panel_code": "EN",
        "panel_name": "Ear, Nose, Throat",
        "count": 45,
        "median_days": 160,
        "p90_days": 265
      },
      {
        "panel_code": "OP",
        "panel_name": "Ophthalmic",
        "count": 33,
        "median_days": 146,
        "p90_days": 268
      },
      {
        "panel_code": "IM",
        "panel_name": "Immunology",
        "count": 20,
        "median_days": 144,
        "p90_days": 324
      },
      {
        "panel_code": "HE",
        "panel_name": "Hematology",
        "count": 12,
        "median_days": 214,
        "p90_days": 268
      },
      {
        "panel_code": "TX",
        "panel_name": "Clinical Toxicology",
        "count": 11,
        "median_days": 112,
        "p90_days": 185
      },
      {
        "panel_code": "PA",
        "panel_name": "Pathology",
        "count": 10,
        "median_days": 227.5,
        "p90_days": 266
      },
      {
        "panel_code": "MG",
        "panel_name": "Medical Genetics",
        "count": 1,
        "median_days": 349,
        "p90_days": 349
      }
    ]
  },
  "top_25_product_codes": {
    "year": 2025,
    "rows": [
      {
        "product_code": "QIH",
        "panel_name": "Radiology",
        "count": 94,
        "median_days": 150
      },
      {
        "product_code": "GEX",
        "panel_name": "General, Plastic Surgery",
        "count": 83,
        "median_days": 90
      },
      {
        "product_code": "LLZ",
        "panel_name": "Radiology",
        "count": 58,
        "median_days": 173
      },
      {
        "product_code": "IYN",
        "panel_name": "Radiology",
        "count": 57,
        "median_days": 124
      },
      {
        "product_code": "HRS",
        "panel_name": "Orthopedic",
        "count": 54,
        "median_days": 90
      },
      {
        "product_code": "GEI",
        "panel_name": "General, Plastic Surgery",
        "count": 52,
        "median_days": 113
      },
      {
        "product_code": "OHS",
        "panel_name": "General, Plastic Surgery",
        "count": 42,
        "median_days": 88.5
      },
      {
        "product_code": "NHA",
        "panel_name": "Dental",
        "count": 40,
        "median_days": 146.5
      },
      {
        "product_code": "OLO",
        "panel_name": "Neurology",
        "count": 40,
        "median_days": 119
      },
      {
        "product_code": "DZE",
        "panel_name": "Dental",
        "count": 31,
        "median_days": 184
      },
      {
        "product_code": "ITI",
        "panel_name": "Physical Medicine",
        "count": 29,
        "median_days": 90
      },
      {
        "product_code": "MAX",
        "panel_name": "Orthopedic",
        "count": 29,
        "median_days": 85
      },
      {
        "product_code": "DXN",
        "panel_name": "Cardiovascular",
        "count": 28,
        "median_days": 141.5
      },
      {
        "product_code": "JAK",
        "panel_name": "Radiology",
        "count": 27,
        "median_days": 141
      },
      {
        "product_code": "MBI",
        "panel_name": "Orthopedic",
        "count": 27,
        "median_days": 58
      },
      {
        "product_code": "LNH",
        "panel_name": "Radiology",
        "count": 26,
        "median_days": 122
      },
      {
        "product_code": "HGX",
        "panel_name": "Obstetrics/Gynecology",
        "count": 26,
        "median_days": 121.5
      },
      {
        "product_code": "OHT",
        "panel_name": "General, Plastic Surgery",
        "count": 25,
        "median_days": 87
      },
      {
        "product_code": "NKB",
        "panel_name": "Orthopedic",
        "count": 24,
        "median_days": 61
      },
      {
        "product_code": "LZA",
        "panel_name": "General Hospital",
        "count": 24,
        "median_days": 109.5
      },
      {
        "product_code": "OWB",
        "panel_name": "Radiology",
        "count": 22,
        "median_days": 147.5
      },
      {
        "product_code": "DQK",
        "panel_name": "Cardiovascular",
        "count": 22,
        "median_days": 94.5
      },
      {
        "product_code": "DQY",
        "panel_name": "Cardiovascular",
        "count": 21,
        "median_days": 115
      },
      {
        "product_code": "GCJ",
        "panel_name": "Gastroenterology, Urology",
        "count": 21,
        "median_days": 108
      },
      {
        "product_code": "JWH",
        "panel_name": "Orthopedic",
        "count": 20,
        "median_days": 55
      }
    ]
  },
  "decision_type_mix_by_year": [
    {
      "year": 2021,
      "total": 2993,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 2980
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 8
        },
        {
          "decision_code": "SESU",
          "decision_description": "Unknown",
          "count": 5
        }
      ]
    },
    {
      "year": 2022,
      "total": 3187,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 3178
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 5
        },
        {
          "decision_code": "SESU",
          "decision_description": "Unknown",
          "count": 3
        },
        {
          "decision_code": "SESD",
          "decision_description": "Unknown",
          "count": 1
        }
      ]
    },
    {
      "year": 2023,
      "total": 3299,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 3283
        },
        {
          "decision_code": "SESU",
          "decision_description": "Unknown",
          "count": 9
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 7
        }
      ]
    },
    {
      "year": 2024,
      "total": 3082,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 3074
        },
        {
          "decision_code": "SESU",
          "decision_description": "Unknown",
          "count": 6
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 2
        }
      ]
    },
    {
      "year": 2025,
      "total": 3198,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 3186
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 6
        },
        {
          "decision_code": "SESU",
          "decision_description": "Unknown",
          "count": 5
        },
        {
          "decision_code": "SESD",
          "decision_description": "Unknown",
          "count": 1
        }
      ]
    },
    {
      "year": 2026,
      "total": 2645,
      "mix": [
        {
          "decision_code": "SESE",
          "decision_description": "Substantially Equivalent",
          "count": 2643
        },
        {
          "decision_code": "SESK",
          "decision_description": "Unknown",
          "count": 2
        }
      ]
    }
  ],
  "third_party_vs_direct_by_year": [
    {
      "year": 2021,
      "third_party": {
        "count": 73,
        "median_days": 31
      },
      "direct": {
        "count": 2920,
        "median_days": 137.5
      }
    },
    {
      "year": 2022,
      "third_party": {
        "count": 68,
        "median_days": 29
      },
      "direct": {
        "count": 3119,
        "median_days": 147
      }
    },
    {
      "year": 2023,
      "third_party": {
        "count": 68,
        "median_days": 25.5
      },
      "direct": {
        "count": 3231,
        "median_days": 139
      }
    },
    {
      "year": 2024,
      "third_party": {
        "count": 54,
        "median_days": 28
      },
      "direct": {
        "count": 3028,
        "median_days": 131
      }
    },
    {
      "year": 2025,
      "third_party": {
        "count": 60,
        "median_days": 27
      },
      "direct": {
        "count": 3138,
        "median_days": 127
      }
    },
    {
      "year": 2026,
      "third_party": {
        "count": 52,
        "median_days": 28
      },
      "direct": {
        "count": 2593,
        "median_days": 134
      }
    }
  ]
}