Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Covalontechnologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
269 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 | 269 | 0 |
| K150550 | SilverCoat Silicone Foley Catheter | Covalontechnologies, Inc. | 2015-11-24 | 266 | 0 |
| K121819 | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WI | Covalontechnologies, Inc. | 2012-08-13 | 53 | 0 |
| K112549 | IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH | Covalontechnologies, Inc. | 2012-05-04 | 246 | 0 |
| K043296 | COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING | Covalontechnologies, Inc. | 2005-06-06 | 189 | 0 |
| K050177 | COLACTIVE COLLAGEN WOUND DRESSING | Covalontechnologies, Inc. | 2005-04-27 | 91 | 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