FDA applicant
Pentax of America, Inc.
FDA records 44 decisions for Pentax of America, Inc. (Montvale, NJ) from 2012 to 2025: 44 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and ODG (Endoscopic Ultrasound System…). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 60 predicates, 23 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pentax of America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Pentax of America, Inc.’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”
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