Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chemence Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
318 daysmedian FDA review time
368 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212246 | Exofin Precision Pen | Chemence Medical, Inc. | 2021-09-09 | 52 | 0 |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | Chemence Medical, Inc. | 2020-12-17 | 318 | 0 |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2020-06-05 | 368 | 0 |
| K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2017-09-25 | 132 | 0 |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | Chemence Medical, Inc. | 2016-12-22 | 121 | 0 |
| K050757 | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIV | Chemence Medical, Inc. | 2006-02-23 | 337 | 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