FDA applicant
Pentax Precision Instrument Corp.
FDA records 67 decisions for Pentax Precision Instrument Corp. (Miramar, FL) from 1979 to 2004: 67 510(k) clearances. Most are in product codes FDF (Colonoscope And Accessories, Flexible/Rigid) and EOQ (Bronchoscope (Flexible Or Rigid)). Its devices cite 61 predicates, 45 of them its own earlier devices. 22 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pentax Precision Instrument Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pentax Precision Instrument Corp. since 2007.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Pentax Precision Instrument Corp.’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.