Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biodermis Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003948 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 2001-01-29 | 39 | 0 |
| K992146 | SCARAID SILICONE GEL SHEETING | Biodermis Corp. | 1999-07-30 | 36 | 0 |
| K991604 | EPI-FOAM SILICONE SHEETING | Biodermis Corp. | 1999-06-09 | 30 | 0 |
| K964047 | CRYOSIL SILICONE GEL SHEETING | Biodermis Corp. | 1997-03-19 | 161 | 0 |
| K942156 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 1994-06-13 | 41 | 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