# K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Dec 17, 2013 after 144 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: 4 generations back to K884836 (1988). 9 ancestors in all.
2 later devices descend 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)
- K102855: Universal Irrigation Solution Hybrid, Byrne Medical, Inc. (2010) Summary page 1.
- K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes, Erbe USA, Inc. (2011) Summary page 1.

## Most influential descendants
- K162152: Erbe’s CO2 Tubing/Cap Sets (2016), 1 descendant of its own
- 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
The EIIBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.

Source page: https://510kreport.com/device/K132340
Methodology: https://510kreport.com/methodology