# K181084: PENTAX Video Colonoscopes (EC Family)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jan 18, 2019 after 269 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 29 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 4.

## Most influential descendants
- K192588: G-EYE System (2020), 2 descendants of its own
- K202469: G-EYE System (2020), 1 descendant of its own
- K220158: G-EYE System (2022), 0 descendants 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

## 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/K181084
Methodology: https://510kreport.com/methodology