# K153588: EndoChoice Water Bottle Cap System

- Pathway: 510(k) (Special)
- Applicant: Endochoice, Inc.
- Decided: Feb 24, 2016 after 70 days
- Product code: FEQ (Pump, Air, Non-Manual, For Endoscope)
- 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: 2 generations back to K120123 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142155: Endochoice Water Bottle Cap System, Endochoice, Inc. (2015) Summary page 5.

## Indications for use
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

Source page: https://510kreport.com/device/K153588
Methodology: https://510kreport.com/methodology