# K160287: Rapid Barostat Bag (RBB) Pump and Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mui Scientific
- Decided: Mar 14, 2017 after 405 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: 1 generation back to K973844 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K991288: Distender Series II Barostat, G & J Electronics, Inc. (1999) Summary page 5.
- K973844: Gastric and Rectal Catheters, G & J Electronics, Inc. (1999) Summary page 5.

## Most influential descendants
- K262621: Rapid Barostat Bag (RBB) Pump and Catheter System (2026), 0 descendants of its own

## 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/K160287
Methodology: https://510kreport.com/methodology