Research / FDAPulse
510(k) Clearance & Device Recall Radar: 2026 statistics from 764 public records
California leads with 76 of 764 records (9.9%), ahead of Georgia with 69 (9.0%) (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Key findings
- Zalwin's FDAPulse dataset holds 764 FDAPulse records dated 2026-09-11 to 2026-10-28 (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- California leads with 76 of 764 records (9.9%), ahead of Georgia with 69 (9.0%) (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- The most common medical specialty / review panel is Other: 399 of 764 records (52.2%) (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- Across 414 records with a stated amount, the total is 64,501 and the median is 138; the largest is 806 (SmartIPL_NI System (K241973)) (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- The top 10% of records by amount (41 of 414) account for 21.1% of the total (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- 500 of 764 records (65.4%) are dated within the 30 days before 2026-11-03 (source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
- In California, the leading medical specialty / review panel is Other with 26 of 76 records (34.2%) (as of 2026-11-03; source: U.S. FDA openFDA (510(k) clearances and device enforcement reports)). #
FDAPulse records by state
| Group | Records | Share |
|---|---|---|
| California | 76 | 9.9% |
| Georgia | 69 | 9.0% |
| Illinois | 57 | 7.5% |
| Massachusetts | 41 | 5.4% |
| Delaware | 25 | 3.3% |
| Ohio | 25 | 3.3% |
| Pennsylvania | 19 | 2.5% |
| New Jersey | 18 | 2.4% |
| Virginia | 18 | 2.4% |
| Washington | 17 | 2.2% |
| Florida | 16 | 2.1% |
| Indiana | 13 | 1.7% |
| Minnesota | 12 | 1.6% |
FDAPulse records by medical specialty / review panel
| Group | Records | Share |
|---|---|---|
| Other | 399 | 52.2% |
| Radiology | 56 | 7.3% |
| Orthopedic | 53 | 6.9% |
| Cardiovascular | 52 | 6.8% |
| General & Plastic Surgery | 44 | 5.8% |
| Dental | 32 | 4.2% |
| Gastroenterology & Urology | 27 | 3.5% |
| Neurology | 23 | 3.0% |
| Microbiology | 21 | 2.7% |
| Clinical Chemistry | 15 | 2.0% |
| General Hospital | 14 | 1.8% |
| Anesthesiology | 12 | 1.6% |
| Obstetrics & Gynecology | 9 | 1.2% |
| Ophthalmic | 7 | 0.9% |
Methodology and data provenance
- Sample: 764 public records dated 2026-09-11 to 2026-10-28; illustrative samples excluded.
- Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports). Refreshed automatically about every 12 hours; figures above are as of 2026-11-03.
- Shares are of all records in the dataset; totals and medians use only records with a stated amount.
- Organization-level data only. Informational; verify individual records at the official source.
Cite this study
Zalwin Research, "FDAPulse statistics" (data as of 2026-11-03), https://zalwin.com/research/fdapulse