# Pentax Medical Company

- Location (FDA's records): Montvale, NJ
- FDA decisions: 18 (2004–2019): 18 510(k) clearances
- Names in FDA's records: Pentax Medical Company (12); Pentax Medical (6)
- Product codes: FDT (4), EOQ (3), ODG (3), EOB (2), GCJ (2), FDF (2), PEA (1), FDS (1)
- 510(k) review time since 2016: median 366 days, against 159 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 27 (4 its own); citations of its devices by later devices: 40 (4 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus Medical Systems Corp.: 6 (https://510kreport.com/company/olympus-medical-systems)
- Pentax Precision Instrument Corp.: 6 (https://510kreport.com/company/pentax-precision-instrument)
- Hitachi Medical Systems America, Inc.: 4 (https://510kreport.com/company/hitachi-medical-systems-america)
- Pentax of America, Inc.: 3 (https://510kreport.com/company/pentax-of-america)
- Carl Zeiss, Inc.: 2 (https://510kreport.com/company/carl-zeiss)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Olympus Optical Co., Ltd.: 1 (https://510kreport.com/company/olympus-optical)

## Firms that cite its devices most
- Pentax of America, Inc.: 29 (https://510kreport.com/company/pentax-of-america)
- Mauna Kea Technologies: 4 (https://510kreport.com/company/mauna-kea-technologies)
- Pentax Medical of America, Inc.: 2 (https://510kreport.com/company/pentax-medical-of-america)
- Optiscan Pty., Ltd.: 1 (https://510kreport.com/company/optiscan)

## Its most-cited devices
- K131902: Pentax Video Upper G.I. Scopes (EG Family) (2014), cited by 8
- K131855: Pentax Video Colonoscopes (EC Family) (2014), cited by 8
- K131028: Pentax Video Bronchoscopes (EB Family) (2014), cited by 3
- K122470: Pentax Epk-I5010 Video Processor (2013), cited by 3
- K042740: Isc-1000 Pentax Confocal Laser System (2004), cited by 3
- K172156: PENTAX Medical EPK-3000 Video Imaging System (2018), cited by 2

## Recent decisions
- K192280: PENTAX Medical ED-3490TK Video Duodenoscope (Oct 21, 2019)
- K171011: PENTAX Medical VIVIDEO ENT Videoscope Solution (Jul 18, 2018)
- K172156: PENTAX Medical EPK-3000 Video Imaging System (Apr 5, 2018)
- K161222: PENTAX MEDICAL ED-3490TK, Video Duodenoscope (Feb 7, 2018)
- K163614: PENTAX Medical ED34-i10T, Video Duodenoscope (Sep 20, 2017)
- K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus (Apr 25, 2014)
- K131028: Pentax Video Bronchoscopes (EB Family) (Apr 10, 2014)
- K131902: Pentax Video Upper G.I. Scopes (EG Family) (Apr 10, 2014)

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