# K221177: Erbe's Tubing/Cap Sets

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Aug 11, 2022 after 108 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: 6 generations back to K884836 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes, Erbe USA, Inc. (2011) Summary page 4.
- K162152: Erbe’s CO2 Tubing/Cap Sets, Erbe USA, Inc. (2016) Summary page 4.

## Recalls of this device
- Mar 31, 2026 · Class II · Z-2063-2026: 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 Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.

Source page: https://510kreport.com/device/K221177
Methodology: https://510kreport.com/methodology