Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Amerx Health Care Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025 | Amerx Health Care Corp. | 2009-07-30 | 21 | 0 |
| K971918 | AMERIGEL OINTMENT SATURATED WOUND DRESSING | Amerx Health Care Corp. | 1997-08-12 | 81 | 11 |
| K970133 | AMERIGEL OINTMENT | Amerx Health Care Corp. | 1997-04-14 | 89 | 1 |
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