Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Hymed Group Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | The Hymed Group Corp. | 2014-06-19 | 276 | 0 |
| K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | The Hymed Group Corp. | 2006-12-20 | 232 | 0 |
| K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | The Hymed Group Corp. | 2000-03-22 | 90 | 0 |
| K961930 | CHONDROPROTEC | The Hymed Group Corp. | 1996-10-15 | 151 | 0 |
| K960686 | HYCOAT | The Hymed Group Corp. | 1996-08-12 | 174 | 0 |
| K955506 | HYCURE | The Hymed Group Corp. | 1996-01-17 | 47 | 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