Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovacyn, 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) |
|---|---|---|---|---|---|
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 | 210 | 0 |
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2024-05-31 | 323 | 0 |
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydr | Innovacyn, Inc. | 2015-11-19 | 238 | 0 |
| K133542 | PURACYN PLUS SKIN AND WOUND | Innovacyn, Inc. | 2014-04-28 | 161 | 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