Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultralite — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
152 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910091 | ULTRALITE PANELITE | Ultralite | 1991-05-30 | 141 | 0 |
| K861963 | ULTRALITE HF1236 HAND AND FOOT SYSTEM | Ultralite | 1986-06-25 | 36 | 0 |
| K820492 | SPECTRA305 | Ultralite | 1982-03-31 | 36 | 0 |
| K820280 | SPECTRA 305/350 | Ultralite | 1982-03-05 | 31 | 0 |
| K827123 | SPECTRA (ULTRAVIOLET PRODUCTS) | Ultralite | 1982-03-05 | 31 | 0 |
| K761179 | PSORALITE | Ultralite | 1977-05-03 | 152 | 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