# K250145: Biopsy Port Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Endosound, Inc.
- Decided: Oct 17, 2025 after 269 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: 11 generations back to K894632 (1989). 61 ancestors in all.
No later device cites it as a predicate yet.
1 of 62 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor, STERIS Corporation (2021) Summary page 4.
- K163248: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle, Boston Scientific Corporation (2017) Summary page 4.

## Indications for use
The single-use Biopsy Port Adapter (BPA) converts the biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. This adapter supports luer-lock-connector fine needle biopsy (FNB) and fine needle aspiration (FNA) devices used during an EndoSound EVS endoscopic procedure, while maintaining scope suction.

Source page: https://510kreport.com/device/K250145
Methodology: https://510kreport.com/methodology