# K222734: Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Diversatek Healthcare
- Decided: Nov 8, 2022 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: 1 generation back to K101146 (2010). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140405: Torrent Irrigation System, United States Endoscopy Group, Inc. (2014) Summary page 4.
- K101146: Water Bottle Cap System, United States Endoscopy Group, Inc. (2010) Summary page 5.
- K191559: AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM, United States Endoscopy Group, Inc. (2019) Summary page 5.

## Indications for use
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles. The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO?2 is intended to be used with an air or carbon dioxide (C0O2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.

Source page: https://510kreport.com/device/K222734
Methodology: https://510kreport.com/methodology