# K102409: Defendo Disposable Air/Water Valve Model 100304

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Nov 4, 2010 after 72 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: 1 generation back to K001241 (2000). 1 ancestor in all.
21 later devices descend from it; 9 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001241: Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I, The Olympus Optical Co. (2000)

## Most influential descendants
- K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (2021), 7 descendants of its own
- K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (2023), 3 descendants of its own
- K220210: Disposable Endoscopy Adapter Set (2022), 3 descendants of its own
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (2024), 1 descendant of its own
- K220884: Disposable Endoscope Valve Sets (2023), 1 descendant of its own

## Indications for use
The DEFENDOTm Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

Source page: https://510kreport.com/device/K102409
Methodology: https://510kreport.com/methodology
