# K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R)

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Jul 2, 2009 after 94 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
No predicates in its family tree.
18 later devices descend from it; 9 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (2021), 7 descendants of its own
- K220210: Disposable Endoscopy Adapter Set (2022), 3 descendants of its own
- K110088: Defendo Y-Opsy Irrigator (2011), 2 descendants of its own
- K220884: Disposable Endoscope Valve Sets (2023), 1 descendant of its own
- K210625: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve (2021), 1 descendant of its own

## Indications for use
The DEFENDOTM Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

Source page: https://510kreport.com/device/K090851
Methodology: https://510kreport.com/methodology