Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avitar, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973260 | HYDRASORB STERILE DRESSING | Avitar, Inc. | 1997-10-21 | 53 | 0 |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | 1993-05-12 | 175 | 0 |
| K897102 | HYDRASORB(TM) | Avitar, Inc. | 1990-04-23 | 123 | 0 |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | 1990-02-21 | 57 | 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