Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dermatron Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
48 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770862 | BLACK LAMPS,F72T12/BL/HO | Dermatron Corp. | 1977-06-27 | 48 | 0 |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dermatron Corp. | 1976-12-02 | 9 | 0 |
| K760471 | LAMP, FLOURESCENT BLACK, HIGH OUTPUT | Dermatron Corp. | 1976-09-15 | 27 | 0 |
| K760482 | SUNLAMP (F40-UVB & F20-UVB) | Dermatron Corp. | 1976-09-15 | 27 | 0 |
| K760519 | SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 | Dermatron Corp. | 1976-09-03 | 8 | 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