# K182444: ERBEFLO Olympus Scope Port Connector

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Nov 6, 2018 after 60 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: 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.

## Indications for use
The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures.

Source page: https://510kreport.com/device/K182444
Methodology: https://510kreport.com/methodology