# K904669: Balloon Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Mar 15, 1991 after 151 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962925: Olympus B-5/B-7 Seriesballoon Catheter (1996), 3 descendants of its own
- K962901: Olympus B5-2C/B7-2C Balloon Catheter (1996), 2 descendants of its own
- K033333: Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B (2003), 1 descendant of its own
- K250409: Disposable Balloon Catheter  (B5-2Q); Disposable Balloon Catheter  (B7-2Q); Disposable Balloon Catheter  (B7-2LA) (2025), 0 descendants of its own
- K250118: Disposable Balloon Catheter B5-2C (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K904669
Methodology: https://510kreport.com/methodology