Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synedgen, Inc. — 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) |
|---|---|---|---|---|---|
| K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore an | Synedgen, Inc. | 2020-05-27 | 177 | 0 |
| K172338 | Catasyn Advanced Technology Wound Hydrogel | Synedgen, Inc. | 2018-02-21 | 203 | 0 |
| K143444 | SynePure Wound Cleanser | Synedgen, Inc. | 2015-08-21 | 262 | 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