# K140753: Endo Smart Bottle, Rinse and Insufflation System

- Pathway: 510(k) (Special)
- Applicant: Medivators
- Decided: Jul 15, 2014 after 111 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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 K790071 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 3.

## Most influential descendants
- K181418: ScopeFlow Pure (TM) (2019), 0 descendants of its own

## Indications for use
The EndoSmart Bottle is intended to be used with an air or C02 source and/or a pump along with a sterile water source to supply air or C02 and sterile water to an endoscope during endoscopic procedures.

Source page: https://510kreport.com/device/K140753
Methodology: https://510kreport.com/methodology