Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Klafs Sunlight Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873430 | FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12 | Klafs Sunlight Corp. | 1987-09-25 | 30 | 0 |
| K812225 | METEC HELARIUM LOUNGE & SKY UNITS | Klafs Sunlight Corp. | 1982-03-15 | 217 | 0 |
| K812521 | SUNTANNING DEVICE (SEPAR. FROM K812225) | Klafs Sunlight Corp. | 1981-10-02 | 30 | 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