# K190469: ERBEFLO 2 Disposable Tubing System

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: May 23, 2019 after 86 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924102 (1992). 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)
- K103235: Erbeflo 2 Disposable Tubing System, Erbe USA, Inc. (2010) Summary page 4.

## Recalls of this device
- Mar 31, 2026 · Class II · Z-2064-2026: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip u

## Indications for use
The ERBEFLO® 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/K190469
Methodology: https://510kreport.com/methodology