# K122294: Pressurized Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mui Scientific
- Decided: Nov 1, 2012 after 93 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mui Scientific's Nitrogen gas model of the pressurized infusion pump: named in the summary without a submission number

## Indications for use
The Pressurized Infusion Pump (Electrically Powered Models #PIP-4-4SS, PIP-4-6SS, PIP-4-8SS, PIP-4-12SS, and Portable Models #PIP-6-4SS, PIP-6-6SS, PIP-6-8SS, PIP-6-12SS, PIP-6-16SS, PIP-6-22SS, PIP-6-24SS, PIP-6-36SS) is intended to provide a regulated and channeled perfusate of water to a motility catheter to perform manometric motility studies along the gastrointestinal tract. The Pressurized Infusion Pump is intended to be used with a separate legally marketed compatible motility catheter and separate computerized gastrointestinal monitoring system.

Source page: https://510kreport.com/device/K122294
Methodology: https://510kreport.com/methodology