FDA 510(k) Clearances - October 2022
295 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
October 2022 overview
The FDA cleared 295 medical devices in October 2022 through the 510(k) premarket notification pathway. This compares to 279 clearances in September 2022 - an increase of 16 (+5.7%).
Orthopedic led all specialties with 52 cleared devices. The fastest average review was Gastroenterology & Urology at 107 days. The slowest was Chemistry at 401 days.
Overall average review time: 173 days, ranging from 5 to 879 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 2022
Detailed data
Review time in calendar days from FDA receipt to decision. Source: FDA 510(k) downloadable files.
| Specialty | Cleared | Avg days | Min | Max | vs September |
|---|---|---|---|---|---|
| Orthopedic | 52 | 136 | 26 | 495 | +13 |
| General Hospital | 46 | 198 | 5 | 879 | - |
| General & Plastic Surgery | 39 | 131 | 26 | 733 | -11 |
| Radiology | 30 | 130 | 22 | 531 | -3 |
| Cardiovascular | 27 | 228 | 30 | 667 | +11 |
| Dental | 25 | 225 | 30 | 795 | -3 |
| Neurology | 12 | 167 | 25 | 445 | -6 |
| Physical Medicine | 12 | 188 | 60 | 380 | +9 |
| Gastroenterology & Urology | 11 | 107 | 26 | 274 | -5 |
| Microbiology | 9 | 202 | 59 | 320 | +6 |
| Anesthesiology | 8 | 224 | 90 | 389 | +7 |
| Ophthalmic | 6 | 150 | 83 | 214 | - |
| Obstetrics & Gynecology | 6 | 112 | 28 | 263 | -4 |
| Chemistry | 4 | 401 | 119 | 683 | +2 |
| Ear, Nose, Throat | 4 | 116 | 58 | 202 | +1 |
| Hematology | 2 | 370 | 341 | 399 | +1 |
| Immunology | 2 | 262 | 164 | 360 | - |
| Total | 295 | 173 | 5 | 879 | +16 |
Key observations
Fastest reviews
The fastest individual clearance took 5 days. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 879 days. Extended reviews typically indicate additional information requests or complex predicate device questions. The FDA's standard target is 90 days from receipt.
Leading specialty: Orthopedic
Orthopedic led October 2022 with 52 clearances - 18% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 401 days. Gastroenterology & Urology was fastest at 107 days. The gap of 294 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2022 were Roche Diagnostics (3) , Arthrex, Inc. (3) , Smith & Nephew, Inc. (2) , Terrats Medical SL (2) and Depuy Ireland UC (2) . Together, these five manufacturers accounted for 12 of the 295 total clearances - 4% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 2022 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published on the 5th of each month and in the public domain (17 U.S.C. § 105). Only cleared decisions are counted (SESE, SESK, SESU, SEKD, SESP, SESD, ST, SN).
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