# K103235: Erbeflo 2 Disposable Tubing System

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Dec 23, 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: 1 generation back to K924102 (1992). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924102: Needle, United States Endoscopy Group, Inc. (1992) Summary page 1.

## Most influential descendants
- K143186: Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector (2014), 1 descendant of its own
- K191438: ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (2019), 0 descendants of its own
- K190469: ERBEFLO 2 Disposable Tubing System (2019), 0 descendants of its own
- K182444: ERBEFLO Olympus Scope Port Connector (2018), 0 descendants of its own

## Indications for use
The ERBEFLOTM 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.

Source page: https://510kreport.com/device/K103235
Methodology: https://510kreport.com/methodology