# K193250: Irrigation Tubing with CO2 or Air

- Pathway: 510(k) (Traditional)
- Applicant: Keymed (Medical and Industrial Equipment), Ltd.
- Decided: Apr 6, 2020 after 133 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: 4 generations back to K884836 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 4.

## Indications for use
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or air insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.

Source page: https://510kreport.com/device/K193250
Methodology: https://510kreport.com/methodology