# K251256: PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Dec 16, 2025 after 237 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131902: Pentax Video Upper G.I. Scopes (EG Family), Pentax Medical Company (2014) Summary page 6.
- K131855: Pentax Video Colonoscopes (EC Family), Pentax Medical Company (2014) Summary page 6.

## Indications for use
PENTAX Medical Video Upper GI Scopes (EG Family): 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 upper digestive tract including the esophagus, stomach, and duodenum. PENTAX Medical Video Colonoscopes (EC Family): 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/K251256
Methodology: https://510kreport.com/methodology