# K232004: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector

- Pathway: 510(k) (Traditional)
- Applicant: Medivators (A Subsidiary of Steris Corporation)
- Decided: Mar 6, 2024 after 244 days
- Product code: ODC (Endoscope Channel Accessory)
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102409: Defendo Disposable Air/Water Valve Model 100304, Byrne Medical, Inc. (2010) Summary page 6.
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 6.
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R), Byrne Medical, Inc. (2009) Summary page 6.
- K220395: EndoGator Endoscopy Irrigation Tubing, STERIS Corporation (2022) Summary page 6.
- K092429: Endogator, Byrne Medical, Inc. (2009) Summary page 10.

## Indications for use
The Defendo Pentax Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

Source page: https://510kreport.com/device/K232004
Methodology: https://510kreport.com/methodology