Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IOB — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
341 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903660 | DERMALIGHT PSORACOMB | Solitec GmbH | 1991-07-17 | 341 | 2 |
| K910091 | ULTRALITE PANELITE | Ultralite | 1991-05-30 | 141 | 0 |
| K842276 | SUNMASTER | Mt. Hood Mfr., Inc. | 1984-07-16 | 38 | 0 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | 1982-01-28 | 49 | 0 |
| K812853 | OSRAM UVA LAMP | Osram GmbH | 1981-12-09 | 57 | 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