Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Penlon Limited — 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) |
|---|---|---|---|---|---|
| K060331 | SIGMA ALPHA VAPORIZER | Penlon Limited | 2006-05-10 | 90 | 0 |
| K053564 | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 534 | Penlon Limited | 2006-03-03 | 71 | 0 |
| K051222 | AV-S ANAESTHESIA VENTILATOR | Penlon Limited | 2005-09-23 | 134 | 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