# K962901: Olympus B5-2C/B7-2C Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Aug 20, 1996 after 26 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- 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 K904669 (1991). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904669: Balloon Catheters, Olympus Corp. (1991) Summary page 1.

## Most influential descendants
- K250118: Disposable Balloon Catheter B5-2C (2025), 0 descendants of its own
- K171492: B7 2C Occlusion Balloon (2017), 0 descendants of its own

## Indications for use
Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade).

Source page: https://510kreport.com/device/K962901
Methodology: https://510kreport.com/methodology