# K122470: Pentax Epk-I5010 Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Apr 10, 2013 after 240 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- 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). 33 ancestors in all.
6 later devices descend from it; 3 cite it directly.
3 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112680: Evis Exera Iii Video System, Olympus Medical Systems Corporation (2012) Summary page 3.
- K113873: Pentax Epk-I5020 Video Processor, Pentax of America, Inc. (2012) Summary page 2.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 3.

## Most influential descendants
- K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family (2015), 3 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
- 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
- K251127: PENTAX Medical Video Processor (EPK-i8020c) (2025), 0 descendants of its own
- K232249: PENTAX Medical Gas/Water Feeding Valve OE-B14 (2023), 0 descendants of its own

## Indications for use
The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

Source page: https://510kreport.com/device/K122470
Methodology: https://510kreport.com/methodology