FDA 510(k) Clearances - September 2026
315 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2026 overview
The FDA cleared 315 medical devices in September 2026 through the 510(k) premarket notification pathway. This compares to 238 clearances in August 2026 - an increase of 77 (+32.4%).
Orthopedic led all specialties with 45 cleared devices. The fastest average review was Ophthalmic at 107 days. The slowest was Pathology at 263 days.
Overall average review time: 160 days, ranging from 14 to 715 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 2026
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 |
|---|---|---|---|---|---|
| Orthopedic | 45 | 120 | 20 | 446 | +14 |
| Radiology | 42 | 160 | 14 | 490 | +11 |
| General & Plastic Surgery | 39 | 169 | 28 | 715 | +7 |
| Cardiovascular | 37 | 198 | 42 | 358 | +13 |
| Gastroenterology & Urology | 24 | 151 | 29 | 335 | +5 |
| Dental | 24 | 138 | 25 | 270 | +8 |
| Neurology | 18 | 174 | 27 | 364 | -4 |
| Physical Medicine | 16 | 160 | 58 | 301 | +9 |
| General Hospital | 15 | 143 | 48 | 273 | +3 |
| Obstetrics & Gynecology | 11 | 205 | 28 | 286 | +3 |
| Microbiology | 10 | 128 | 21 | 248 | +4 |
| Chemistry | 10 | 115 | 38 | 252 | +8 |
| Anesthesiology | 9 | 257 | 151 | 448 | -1 |
| Ear, Nose, Throat | 6 | 176 | 65 | 260 | +1 |
| Ophthalmic | 4 | 107 | 51 | 168 | - |
| Hematology | 2 | 216 | 188 | 244 | +1 |
| Immunology | 1 | 214 | 214 | 214 | -4 |
| Pathology | 1 | 263 | 263 | 263 | -2 |
| Toxicology | 1 | 133 | 133 | 133 | +1 |
| Total | 315 | 160 | 14 | 715 | +77 |
Key observations
Fastest reviews
The fastest individual clearance took 14 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 715 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: Orthopedic
Orthopedic led September 2026 with 45 clearances - 14% of all monthly clearances.
Review time spread
Pathology posted the highest average at 263 days. Ophthalmic was fastest at 107 days. The gap of 156 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2026 were Karl Storz SE & CO. KG (5) , Zhenjiang Assure Medical Equipment Co., Ltd. (4) , Arthrex, Inc. (3) , Spident Co., Ltd. (3) and Fujifilm Corporation (3) . Together, these five manufacturers accounted for 18 of the 315 total clearances - 6% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 2026 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published and last updated October 5, 2026 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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