# K962925: Olympus B-5/B-7 Seriesballoon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Oct 25, 1996 after 88 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 5 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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
- 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
- K091495: Single Use 3-Lumen Extraction Balloon V, Model V B-V233P-a,B-V233P-B,B-V433P-a,B-V433P-B, BV243Q-a, B-V243Q-B, B-V443Q-a (2009), 0 descendants of its own

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0962-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0963-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0964-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0965-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0961-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Indications for use
The B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.

Source page: https://510kreport.com/device/K962925
Methodology: https://510kreport.com/methodology