FDA 510(k) Clearances - September 2021
261 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2021 overview
The FDA cleared 261 medical devices in September 2021 through the 510(k) premarket notification pathway. This compares to 285 clearances in August 2021 - a decrease of 24 (-8.4%).
General Hospital led all specialties with 54 cleared devices. The fastest average review was Ear, Nose, Throat at 83 days. The slowest was Immunology at 459 days.
Overall average review time: 171 days, ranging from 4 to 871 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 2021
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 August |
|---|---|---|---|---|---|
| General Hospital | 54 | 180 | 28 | 471 | -8 |
| Radiology | 43 | 117 | 14 | 413 | +1 |
| Orthopedic | 32 | 119 | 17 | 440 | -17 |
| Cardiovascular | 26 | 164 | 28 | 476 | +9 |
| General & Plastic Surgery | 21 | 139 | 21 | 568 | +5 |
| Dental | 17 | 214 | 4 | 436 | -6 |
| Neurology | 14 | 98 | 27 | 264 | -4 |
| Gastroenterology & Urology | 13 | 184 | 27 | 447 | +4 |
| Obstetrics & Gynecology | 9 | 217 | 30 | 444 | - |
| Anesthesiology | 7 | 230 | 30 | 392 | - |
| Chemistry | 7 | 358 | 159 | 536 | -5 |
| Microbiology | 6 | 322 | 26 | 871 | +3 |
| Physical Medicine | 5 | 314 | 24 | 580 | +1 |
| Immunology | 3 | 459 | 376 | 624 | +2 |
| Ear, Nose, Throat | 1 | 83 | 83 | 83 | -5 |
| Ophthalmic | 1 | 215 | 215 | 215 | -2 |
| Toxicology | 1 | 91 | 91 | 91 | -3 |
| Pathology | 1 | 260 | 260 | 260 | +1 |
| Total | 261 | 171 | 4 | 871 | -24 |
Key observations
Fastest reviews
The fastest individual clearance took 4 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 871 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 September 2021 with 54 clearances - 21% of all monthly clearances.
Review time spread
Immunology posted the highest average at 459 days. Ear, Nose, Throat was fastest at 83 days. The gap of 376 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2021 were SeaSpine Orthopedics Corporation (3) , Roche Diagnostics (2) , Samsung Medison Co., Ltd. (2) , Canon, Inc. (2) and Olympus Medical Systems Corp. (2) . Together, these five manufacturers accounted for 11 of the 261 total clearances - 4% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 2021 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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