FDA 510(k) Clearances - June 2021
210 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2021 overview
The FDA cleared 210 medical devices in June 2021 through the 510(k) premarket notification pathway. This compares to 194 clearances in May 2021 - an increase of 16 (+8.2%).
General Hospital led all specialties with 49 cleared devices. The fastest average review was Ear, Nose, Throat at 56 days. The slowest was Immunology at 541 days.
Overall average review time: 161 days, ranging from 17 to 570 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 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 May |
|---|---|---|---|---|---|
| General Hospital | 49 | 158 | 23 | 425 | +15 |
| Orthopedic | 30 | 126 | 21 | 395 | -3 |
| Radiology | 26 | 108 | 17 | 272 | +6 |
| Dental | 21 | 182 | 59 | 570 | +10 |
| General & Plastic Surgery | 19 | 144 | 28 | 357 | -6 |
| Cardiovascular | 14 | 161 | 28 | 441 | -10 |
| Neurology | 11 | 246 | 27 | 550 | +6 |
| Obstetrics & Gynecology | 9 | 114 | 30 | 268 | +4 |
| Physical Medicine | 8 | 246 | 79 | 474 | -3 |
| Gastroenterology & Urology | 8 | 147 | 29 | 263 | -5 |
| Ophthalmic | 4 | 189 | 165 | 224 | - |
| Anesthesiology | 3 | 320 | 207 | 382 | - |
| Microbiology | 2 | 191 | 59 | 323 | +1 |
| Toxicology | 2 | 418 | 414 | 422 | +2 |
| Ear, Nose, Throat | 2 | 56 | 27 | 84 | - |
| Immunology | 1 | 541 | 541 | 541 | - |
| Chemistry | 1 | 269 | 269 | 269 | -1 |
| Total | 210 | 161 | 17 | 570 | +16 |
Key observations
Fastest reviews
The fastest individual clearance took 17 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 570 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 June 2021 with 49 clearances - 23% of all monthly clearances.
Review time spread
Immunology posted the highest average at 541 days. Ear, Nose, Throat was fastest at 56 days. The gap of 485 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2021 were Stryker Corporation (3) , Osteonic Co., Ltd. (3) , Baxter Healthcare Corporation (2) , Waldemar Link GmbH & Co. KG (2) and Institut Straumann AG (2) . Together, these five manufacturers accounted for 12 of the 210 total clearances - 6% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 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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