# K131855: Pentax Video Colonoscopes (EC Family)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Apr 9, 2014 after 292 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931154 (1993). 28 ancestors in all.
13 later devices descend from it; 8 cite it directly.
3 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000) Summary page 1.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 1.

## Most influential descendants
- K181084: PENTAX Video Colonoscopes (EC Family) (2019), 3 descendants of its own
- K192588: G-EYE System (2020), 2 descendants of its own
- K231249: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (2023), 1 descendant of its own
- K202469: G-EYE System (2020), 1 descendant of its own
- K190805: PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL (2019), 1 descendant of its own

## Recalls of this device
- Jul 14, 2021 · Class II · Z-2448-2021: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- Jul 14, 2021 · Class II · Z-2449-2021: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- Jan 3, 2020 · Class II · Z-1268-2020: Distributed in the USA without an approved 510K
- Jan 3, 2020 · Class II · Z-1267-2020: Distributed in the USA without an approved 510K
- Aug 15, 2016 · Class II · Z-0636-2017: Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the oper
- Apr 6, 2016 · Class II · Z-2068-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

## Indications for use
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

Source page: https://510kreport.com/device/K131855
Methodology: https://510kreport.com/methodology