# K191438: ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Jun 27, 2019 after 28 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 K924102 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143186: Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector, Erbe USA, Inc. (2014) Summary page 4.

## 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/K191438
Methodology: https://510kreport.com/methodology