# K142068: Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Medovations, Inc.
- Decided: Mar 10, 2015 after 223 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 K070420 (2007). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070420: Bioshield-Ercp Biopsy Valve, Model 00711138, United States Endoscopy Group, Inc. (2007) Summary page 4.

## Most influential descendants
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (2021), 6 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
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (2024), 1 descendant of its own
- K250145: Biopsy Port Adapter (2025), 0 descendants of its own
- K250140: Defendo Fujifilm 700 Single Use Cleaning Adapter (2025), 0 descendants of its own

## Indications for use
The single use Medovations BullDog® biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K142068
Methodology: https://510kreport.com/methodology