FDA 510(k) Clearances - July 2021
293 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2021 overview
The FDA cleared 293 medical devices in July 2021 through the 510(k) premarket notification pathway. This compares to 210 clearances in June 2021 - an increase of 83 (+39.5%).
General Hospital led all specialties with 63 cleared devices. The fastest average review was Radiology at 104 days. The slowest was Toxicology at 511 days.
Overall average review time: 179 days, ranging from 20 to 652 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 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 June |
|---|---|---|---|---|---|
| General Hospital | 63 | 172 | 28 | 546 | +14 |
| Orthopedic | 40 | 151 | 20 | 491 | +10 |
| Radiology | 40 | 104 | 22 | 371 | +14 |
| General & Plastic Surgery | 34 | 181 | 23 | 456 | +15 |
| Cardiovascular | 31 | 158 | 24 | 447 | +17 |
| Dental | 25 | 204 | 76 | 595 | +4 |
| Gastroenterology & Urology | 10 | 205 | 23 | 492 | +2 |
| Neurology | 10 | 150 | 29 | 408 | -1 |
| Physical Medicine | 6 | 239 | 49 | 652 | -2 |
| Chemistry | 6 | 371 | 142 | 532 | +5 |
| Anesthesiology | 6 | 276 | 137 | 624 | +3 |
| Microbiology | 5 | 315 | 82 | 569 | +3 |
| Obstetrics & Gynecology | 4 | 212 | 88 | 326 | -5 |
| Ear, Nose, Throat | 4 | 154 | 57 | 309 | +2 |
| Ophthalmic | 2 | 174 | 60 | 287 | -2 |
| Toxicology | 2 | 511 | 434 | 588 | - |
| Immunology | 2 | 487 | 352 | 621 | +1 |
| Pathology | 2 | 443 | 334 | 552 | +2 |
| Hematology | 1 | 164 | 164 | 164 | +1 |
| Total | 293 | 179 | 20 | 652 | +83 |
Key observations
Fastest reviews
The fastest individual clearance took 20 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 652 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 July 2021 with 63 clearances - 22% of all monthly clearances.
Review time spread
Toxicology posted the highest average at 511 days. Radiology was fastest at 104 days. The gap of 407 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2021 were Siemens Medical Solutions USA, Inc. (4) , Smith & Nephew, Inc. (3) , Medtronic, Inc. (3) , Siemens Healthcare Diagnostics, Inc. (3) and Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2) . Together, these five manufacturers accounted for 15 of the 293 total clearances - 5% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 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.