FDA applicant
Pentax Medical Company
FDA records 18 decisions for Pentax Medical Company (Montvale, NJ) from 2004 to 2019: 18 510(k) clearances. Most are in product codes FDT (Duodenoscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 366 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 4 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “Pentax Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pentax Medical Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
2in 2021
Class I Class II/III not classified
Planning a device like Pentax Medical Company’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Pentax”
FDA records each applicant name separately; these may or may not be the same firm.