Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hamilton Industries, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
108 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883680 | MEDALIST EXAMINATION TABLE | Hamilton Industries, Inc. | 1988-10-04 | 36 | 0 |
| K792001 | COMFICARE PAD (FOR SINGEL PT USE) | Hamilton Industries, Inc. | 1979-10-26 | 21 | 0 |
| K790871 | ENCLOSED CASE CART | Hamilton Industries, Inc. | 1979-05-14 | 7 | 0 |
| K770956 | PAS ANTI-EMBOLISM SYSTEM | Hamilton Industries, Inc. | 1977-09-12 | 108 | 0 |
| K771018 | TRANS 2000 | Hamilton Industries, Inc. | 1977-07-14 | 38 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda