# K262621: Rapid Barostat Bag (RBB) Pump and Catheter System

- Pathway: 510(k) (Special)
- Applicant: Mui Scientific, Inc.
- Decided: Sep 30, 2026 after 64 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- 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 K973844 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160287: Rapid Barostat Bag (RBB) Pump and Catheter, Mui Scientific (2017) Summary page 5.

## Indications for use
The Rapid Barostat Bag Pump and Catheter are used together for the inflation of a barostat balloon to measure rectal capacity, as well as rectal volume at points of sensation, urge, and discomfort, to determine hypersensitivity, hyposensitivity, or normal rectal sensations. These determinations aid in the diagnosis of anorectal disorders, such as fecal incontinence and constipation.

Source page: https://510kreport.com/device/K262621
Methodology: https://510kreport.com/methodology