Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advamedica, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
723 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212766 | Maxiocel Chitosan Wound Dressing | Advamedica, Inc. | 2023-08-24 | 723 | 0 |
| K222909 | Axiostat Gauze | Advamedica, Inc. | 2023-04-07 | 193 | 0 |
| K213198 | Ax-Surgi Surgical Hemostat | Advamedica, Inc. | 2023-01-05 | 463 | 0 |
| K202830 | Axiostat Patch | Advamedica, Inc. | 2021-04-15 | 202 | 0 |
| K172324 | Axiostat Chitosan Hemostatic Dressing | Advamedica, Inc. | 2018-02-23 | 206 | 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