# K250409: Disposable Balloon Catheter  (B5-2Q); Disposable Balloon Catheter  (B7-2Q); Disposable Balloon Catheter  (B7-2LA)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 21, 2025 after 250 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K904669 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962925: Olympus B-5/B-7 Seriesballoon Catheter, Olympus America, Inc. (1996) Summary page 5.

## Indications for use
The DISPOSABLE BALLOON CATHETER B5-2Q, B7-2Q/2LA have been designed to be used with Olympus endoscopes to inject contrast medium into the biliary or pancreatic track. They can also be used for retrieval of biliary or pancreatic stones.

Source page: https://510kreport.com/device/K250409
Methodology: https://510kreport.com/methodology