Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NAC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | Scivolutions, Inc. | 2008-12-01 | 118 | 0 |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | 1993-05-12 | 175 | 0 |
| K914575 | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | Dow B. Hickam, Inc. | 1991-12-04 | 50 | 0 |
| K914779 | ALGINATE FIBER | Adri/Technam | 1991-12-04 | 42 | 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