# K191282: PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Nov 8, 2019 after 179 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 38 ancestors in all.
No later device cites it as a predicate yet.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family, Pentax of America, Inc. (2015) Summary page 5.
- K122470: Pentax Epk-I5010 Video Processor, Pentax Medical (2013) Summary page 5.
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 6.

## Recalls of this device
- Sep 9, 2026 · Not classified · Z-0310-2027: Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.

## Indications for use
The PENTAX Medical EPK-i7010 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 Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes. 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/K191282
Methodology: https://510kreport.com/methodology