Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Penlon, Inc. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time
319 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936046SIGMA ELITEPenlon, Inc.1994-11-043190
K902381PENLON BREATHING SYSTEM PRESSURE MONITORPenlon, Inc.1990-08-17790
K894689PENLON IDP PRESSURE FAILURE ALARMPenlon, Inc.1989-08-10170
K844008PENLON AM1000 ANAESTHESIA MACHINEPenlon, Inc.1985-03-121510
K844007PENLON PPV VAPORIZERPenlon, Inc.1985-03-121510
K823555MAGTARAK RESPIRATORY MONITOR & FLOW SENSPenlon, Inc.1983-01-05350
K803052NUFFIELD ANESTHESIA VENTILATOR SER. 400Penlon, Inc.1981-01-07360
K801253CREST ELECTRONIC WARMING BLANKETPenlon, Inc.1981-01-022190
K801254PENLON I.D.P. PRESSSURE FAILURE ALARMPenlon, Inc.1980-06-09120
K801255PENLON JUMBO CARBON DIOXIDE ABSORBERPenlon, Inc.1980-06-0470

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