# K162152: Erbe’s CO2 Tubing/Cap Sets

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Aug 31, 2016 after 29 days
- Product code: FEQ (Pump, Air, Non-Manual, For Endoscope)
- 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: 5 generations back to K884836 (1988). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1, Erbe USA, Inc. (2013) Summary page 4.

## Most influential descendants
- K221177: Erbe's Tubing/Cap Sets (2022), 0 descendants of its own

## Recalls of this device
- Mar 31, 2026 · Class II · Z-2062-2026: 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
Erbe's CO2 Tubing/Cap Sets provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

Source page: https://510kreport.com/device/K162152
Methodology: https://510kreport.com/methodology