FDA 510(k) Clearances - August 2021
285 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
August 2021 overview
The FDA cleared 285 medical devices in August 2021 through the 510(k) premarket notification pathway. This compares to 293 clearances in July 2021 - a decrease of 8 (-2.7%).
General Hospital led all specialties with 62 cleared devices. The fastest average review was Radiology at 108 days. The slowest was Immunology at 574 days.
Overall average review time: 168 days, ranging from 21 to 681 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - August 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 July |
|---|---|---|---|---|---|
| General Hospital | 62 | 166 | 43 | 410 | -1 |
| Orthopedic | 49 | 124 | 29 | 481 | +9 |
| Radiology | 42 | 108 | 21 | 447 | +2 |
| Dental | 23 | 208 | 28 | 557 | -2 |
| Neurology | 18 | 232 | 27 | 681 | +8 |
| Cardiovascular | 17 | 166 | 28 | 479 | -14 |
| General & Plastic Surgery | 16 | 160 | 23 | 452 | -18 |
| Chemistry | 12 | 279 | 84 | 494 | +6 |
| Gastroenterology & Urology | 9 | 157 | 28 | 339 | -1 |
| Obstetrics & Gynecology | 9 | 165 | 27 | 337 | +5 |
| Anesthesiology | 7 | 261 | 117 | 477 | +1 |
| Ear, Nose, Throat | 6 | 116 | 28 | 266 | +2 |
| Toxicology | 4 | 306 | 143 | 469 | +2 |
| Physical Medicine | 4 | 196 | 96 | 387 | -2 |
| Microbiology | 3 | 214 | 27 | 521 | -2 |
| Ophthalmic | 3 | 167 | 54 | 340 | +1 |
| Immunology | 1 | 574 | 574 | 574 | -1 |
| Total | 285 | 168 | 21 | 681 | -8 |
Key observations
Fastest reviews
The fastest individual clearance took 21 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 681 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 August 2021 with 62 clearances - 22% of all monthly clearances.
Review time spread
Immunology posted the highest average at 574 days. Radiology was fastest at 108 days. The gap of 466 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in August 2021 were Ge Healthcare (3) , Globus Medical, Inc. (3) , Alpinion Medical Systems Co., Ltd. (2) , Philips Medical Systems Nederland B.V. (2) and Intuitive Surgical, Inc. (2) . Together, these five manufacturers accounted for 12 of the 285 total clearances - 4% of all August activity.
About this data
This report covers FDA 510(k) submissions with a decision date in August 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).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.