# K153483: Balloon controller PB-30

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Dec 15, 2015 after 12 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 4 generations back to K993704 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T, Fujifilm Medical Systems U.S.A, Inc. (2015) Summary page 4.

## Most influential descendants
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (2026), 0 descendants of its own

## Indications for use
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.

Source page: https://510kreport.com/device/K153483
Methodology: https://510kreport.com/methodology