# K181457: EndoStream (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Partnership Medical Limited
- Decided: Jul 11, 2019 after 402 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: 6 generations back to K884836 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 7.
- K161482: EndoChoice Water Bottle Cap Irrigation System, Endochoice, Inc. (2016) Summary page 8.

## Indications for use
The EndoStream™ tubing is intended to provide irrigation via sterile water supply during gastrointestinal (GI) endoscopic procedures when used in conjunction with an irrigation pump.

Source page: https://510kreport.com/device/K181457
Methodology: https://510kreport.com/methodology