# K102855: Universal Irrigation Solution Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Nov 19, 2010 after 51 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: 3 generations back to K884836 (1988). 7 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 15 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 1.
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 (2013), 2 descendants of its own
- K162152: Erbe’s CO2 Tubing/Cap Sets (2016), 1 descendant of its own
- K231418: ENDOGATOR™ Hybrid Irrigation Tubing (2023), 0 descendants of its own
- K231602: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (2023), 0 descendants of its own
- K220785: Clean Connecting Tube (2022), 0 descendants of its own

## Indications for use
The Universal Irrigation Solution HybridTM (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or 002 (via aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

Source page: https://510kreport.com/device/K102855
Methodology: https://510kreport.com/methodology