# PEA: Endoscope, Accessories, Image Post-Processing For Color Enhancement

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 71 days (middle half 62–79)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 2
- 2023: 1
- 2025: 1

## Most-cited predicates
- K140149: Epx-4440HD Digital Video Processor (2014), cited by 4
- K122470: Pentax Epk-I5010 Video Processor (2013), cited by 3
- K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family (2015), cited by 2
- 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), cited by 1
- K231249: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (2023), cited by 1
- K173679: PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (2018), cited by 1

Source page: https://510kreport.com/product-code/PEA
Data by year (CSV): https://510kreport.com/product-code/PEA.csv