# K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 3, 2021 after 210 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: 2 generations back to K070420 (2007). 3 ancestors in all.
6 later devices descend from it; 3 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 5.
- K103239: Irrigation System, United States Endoscopy Group, Inc. (2010) Summary page 5.
- K142068: Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile, Medovations, Inc. (2015) Summary page 5.

## Most influential descendants
- 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
- K243075: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (2024), 0 descendants of its own

## Indications for use
The single-use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation. The BioShield Irrigator — extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator. The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.

Source page: https://510kreport.com/device/K210342
Methodology: https://510kreport.com/methodology