Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sylvania Lighting Products — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852575 | WALDMANN F85/100W PUVA | Sylvania Lighting Products | 1985-08-16 | 59 | 0 |
| K852321 | SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA | Sylvania Lighting Products | 1985-07-11 | 42 | 0 |
| K852684 | WALDMANN F85/100W UV21 | Sylvania Lighting Products | 1985-07-11 | 16 | 0 |
| K852576 | WALDMANN F85/100W UV6 | Sylvania Lighting Products | 1985-07-11 | 23 | 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