Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Daavlin Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063621 | 3 SERIES PHOTOTHERAPY CABINET | Daavlin Co. | 2007-01-17 | 43 | 0 |
| K930856 | PSORALITE | Daavlin Co. | 1993-08-26 | 189 | 0 |
| K854498 | SPECTRA 724 | Daavlin Co. | 1985-11-25 | 13 | 0 |
| K828654 | UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305 | Daavlin Co. | 1983-01-03 | 48 | 0 |
| K827690 | SPECTRA MINI, ULTRAVIOLET EMITTER FOR DERMATOLOGICAL USE | Daavlin Co. | 1982-10-05 | 15 | 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