FDA 510(k) Clearances - October 2021
230 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
October 2021 overview
The FDA cleared 230 medical devices in October 2021 through the 510(k) premarket notification pathway. This compares to 261 clearances in September 2021 - a decrease of 31 (-11.9%).
General Hospital led all specialties with 51 cleared devices. The fastest average review was Ophthalmic at 79 days. The slowest was Immunology at 587 days.
Overall average review time: 185 days, ranging from 12 to 750 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 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 September |
|---|---|---|---|---|---|
| General Hospital | 51 | 160 | 31 | 557 | -3 |
| General & Plastic Surgery | 32 | 209 | 12 | 506 | +11 |
| Orthopedic | 25 | 123 | 29 | 638 | -7 |
| Radiology | 24 | 120 | 21 | 386 | -19 |
| Cardiovascular | 23 | 147 | 24 | 491 | -3 |
| Dental | 16 | 215 | 28 | 521 | -1 |
| Neurology | 12 | 307 | 30 | 597 | -2 |
| Gastroenterology & Urology | 12 | 141 | 29 | 271 | -1 |
| Microbiology | 7 | 295 | 77 | 576 | +1 |
| Obstetrics & Gynecology | 7 | 230 | 60 | 416 | -2 |
| Chemistry | 5 | 445 | 192 | 567 | -2 |
| Ear, Nose, Throat | 4 | 118 | 29 | 206 | +3 |
| Anesthesiology | 4 | 118 | 30 | 185 | -3 |
| Physical Medicine | 4 | 331 | 119 | 750 | -1 |
| Immunology | 2 | 587 | 511 | 662 | -1 |
| Ophthalmic | 2 | 79 | 28 | 129 | +1 |
| Total | 230 | 185 | 12 | 750 | -31 |
Key observations
Fastest reviews
The fastest individual clearance took 12 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 750 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 October 2021 with 51 clearances - 22% of all monthly clearances.
Review time spread
Immunology posted the highest average at 587 days. Ophthalmic was fastest at 79 days. The gap of 508 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2021 were Pentax of America, Inc. (3) , Elekta Solutions AB (2) , El.En Electronic Engineering Spa (2) , STERIS Corporation (2) and Edan Instruments, Inc. (2) . Together, these five manufacturers accounted for 11 of the 230 total clearances - 5% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 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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