# Pentax Precision Instrument Corp.

- Location (FDA's records): Miramar, FL
- FDA decisions: 67 (1979–2004): 67 510(k) clearances
- Product codes: FDF (11), EOQ (9), ODG (7), FDS (7), FAM (6), ITX (4), FDT (3), FBN (3), GCL (2), CAL (2), GCT (2), EOB (2)
- Predicates its devices cite: 61 (45 its own); citations of its devices by later devices: 69 (45 its own)
- Recalls linked to its devices: 22 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hitachi Medical Corp. of America: 6 (https://510kreport.com/company/hitachi-medical-of-america)
- Hitachi Medical Systems America, Inc.: 3 (https://510kreport.com/company/hitachi-medical-systems-america)
- Hitachi Medical Corp.: 3 (https://510kreport.com/company/hitachi-medical)
- Keeler Instruments, Inc.: 1 (https://510kreport.com/company/keeler-instruments)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)
- Mui Scientific: 1 (https://510kreport.com/company/mui-scientific)
- Synectics-Dantec: 1 (https://510kreport.com/company/synectics-dantec)

## Firms that cite its devices most
- Pentax Medical Company: 6 (https://510kreport.com/company/pentax-medical)
- Akos Biomedical, Inc.: 4 (https://510kreport.com/company/akos-biomedical)
- Olympus Optical Co., Ltd.: 3 (https://510kreport.com/company/olympus-optical)
- Sightline Technologies, Ltd.: 3 (https://510kreport.com/company/sightline-technologies)
- Neoguide Systems, Inc.: 2 (https://510kreport.com/company/neoguide-systems)
- Richard Wolf Medical Instruments Corp.: 2 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Vision-Sciences, Inc.: 2 (https://510kreport.com/company/vision-sciences)
- Acmi Corporation: 1 (https://510kreport.com/company/acmi)

## Its most-cited devices
- K934918: Epm-3300 Video Processor (1994), cited by 12
- K951574: EC-3800L, Video Colonoscope (1996), cited by 8
- K934920: VB-1830/VB-1530, Video Bronchoscope (1994), cited by 5
- K951579: EC-3800TL, Video Colonoscope (1996), cited by 4
- K921707: Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 (1992), cited by 4
- K961563: EC-384OTL, Video Colonscope (1996), cited by 3

## Recent decisions
- K041397: EG-3830UT (Jun 9, 2004)
- K041395: EG-3630UR (Jun 9, 2004)
- K041396: FG-36UX Fiber Ultrasound Gastroscope (Jun 9, 2004)
- K031789: EG-3830UT, Video Ultrasound Gastroscope (Aug 8, 2003)
- K023401: EG-3830UT, Video Ultrasound Gastroscope (Feb 11, 2003)
- K023376: EB-1830T3, Video Bronchoscope (Oct 16, 2002)
- K021276: FG-36UX Fiber Ultrasound Gastroscope (Sep 12, 2002)
- K021278: EG-3630UR, Ultrasound Video Gastroscope (Sep 6, 2002)

Source page: https://510kreport.com/company/pentax-precision-instrument