Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Penlon , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
311 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061102 | PRIMA ANAESTHESIA MACHINE | Penlon , Ltd. | 2006-07-28 | 100 | 1 |
| K041076 | DELTA T | Penlon , Ltd. | 2004-08-09 | 105 | 0 |
| K010317 | AV 800 VENTILATOR | Penlon , Ltd. | 2001-07-23 | 171 | 0 |
| K010318 | PRIMA OXYGEN MONITOR | Penlon , Ltd. | 2001-07-23 | 171 | 0 |
| K002343 | SIGMA DELTA | Penlon , Ltd. | 2001-06-08 | 311 | 1 |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | Penlon , Ltd. | 1996-07-16 | 90 | 0 |
| K960944 | PPV VAPORIZER (MODIFICATION) | Penlon , Ltd. | 1996-04-02 | 49 | 0 |
| K953179 | CLM LARYNGOSCOPE | Penlon , Ltd. | 1995-10-06 | 88 | 0 |
| K942545 | SIGMA ELITE | Penlon , Ltd. | 1995-02-03 | 248 | 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