Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Psoralite Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
121 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913760 | PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT | Psoralite Corp. | 1991-10-28 | 67 | 0 |
| K890084 | PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000 | Psoralite Corp. | 1989-05-11 | 121 | 0 |
| K881385 | PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL | Psoralite Corp. | 1988-04-13 | 9 | 0 |
| K864510 | PSORALITE 12800 SERIES | Psoralite Corp. | 1987-02-04 | 82 | 0 |
| K864511 | PSORALITE 18400 SERIES | Psoralite Corp. | 1987-02-04 | 82 | 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