FDA 510(k) Clearances - May 2022
286 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2022 overview
The FDA cleared 286 medical devices in May 2022 through the 510(k) premarket notification pathway. This compares to 257 clearances in April 2022 - an increase of 29 (+11.3%).
General Hospital led all specialties with 57 cleared devices. The fastest average review was Ophthalmic at 129 days. The slowest was Chemistry at 463 days.
Overall average review time: 186 days, ranging from 14 to 788 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| General Hospital | 57 | 183 | 30 | 447 | +13 |
| Orthopedic | 47 | 145 | 20 | 728 | +14 |
| Radiology | 44 | 140 | 18 | 377 | - |
| General & Plastic Surgery | 32 | 159 | 28 | 449 | -1 |
| Cardiovascular | 23 | 201 | 14 | 719 | -8 |
| Neurology | 16 | 161 | 55 | 438 | +2 |
| Gastroenterology & Urology | 13 | 216 | 18 | 441 | -3 |
| Dental | 13 | 238 | 58 | 603 | +1 |
| Chemistry | 8 | 463 | 157 | 788 | +5 |
| Obstetrics & Gynecology | 7 | 168 | 28 | 387 | +1 |
| Physical Medicine | 7 | 190 | 27 | 526 | +4 |
| Microbiology | 5 | 428 | 335 | 535 | +2 |
| Anesthesiology | 5 | 276 | 164 | 413 | -1 |
| Ophthalmic | 4 | 129 | 83 | 228 | - |
| Toxicology | 2 | 291 | 58 | 523 | +1 |
| Hematology | 2 | 224 | 119 | 329 | +1 |
| Ear, Nose, Throat | 1 | 448 | 448 | 448 | -1 |
| Total | 286 | 186 | 14 | 788 | +29 |
Key observations
Fastest reviews
The fastest individual clearance took 14 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 788 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: General Hospital
General Hospital led May 2022 with 57 clearances - 20% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 463 days. Ophthalmic was fastest at 129 days. The gap of 334 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2022 were Siemens Medical Solutions USA, Inc. (4) , Arthrex, Inc. (3) , Medacta International S.A. (3) , Philips Medical Systems Nederland B.V. (3) and Becton, Dickinson and Company (2) . Together, these five manufacturers accounted for 15 of the 286 total clearances - 5% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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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