# FEQ: Pump, Air, Non-Manual, For Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 21
- 510(k) review time 2021–2025: median 28 days (middle half 28–28)
- Recalls: 5 (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)
- 2011: 1
- 2012: 3
- 2013: 1
- 2014: 1
- 2015: 2
- 2016: 3
- 2017: 1
- 2018: 2
- 2019: 1
- 2022: 1

## Most-cited predicates
- K092429: Endogator (2009), cited by 13
- K000948: Olympus Endoscopic Flushing Pump Model Ofp-1 (2000), cited by 5
- K220395: EndoGator Endoscopy Irrigation Tubing (2022), cited by 4
- K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes (2011), cited by 2
- K101146: Water Bottle Cap System (2010), cited by 2
- K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 (2013), cited by 1
- K100899: Olympus Endoscopic Flushing Pump, Model Opf-2 (2010), cited by 1
- K120123: Aquashield CO2 System (2012), cited by 1
- K142155: Endochoice Water Bottle Cap System (2015), cited by 1
- K162152: Erbe’s CO2 Tubing/Cap Sets (2016), cited by 1

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