# K120524: Sphincter of Oddi Manometric (Som) System

- Pathway: 510(k) (Traditional)
- Applicant: Mui Scientific
- Decided: Jun 21, 2012 after 120 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 pressurized infusion pump: named in the summary without a submission number
- (no number) Mui Scientific's (formerly Dentsleeve Pty) manometric perfusion pump and manometric assemblies: named in the summary without a submission number
- (no number) Arndorfer Inc's pneumo-hydraulic capillary infusion system and ERCP manometric catheters: named in the summary without a submission number
- (no number) Cook Medical's Lehman Sphincter of Oddi Manometric catheter: named in the summary without a submission number

## Indications for use
When used in conjunction with a computerized motility system for motility studies, this Sphincter of Oddi Manometric System is used to measure the contraction rates of the Sphincter of Oddi within the gastrointestinal system; for research or diagnostic purposes within a clinical setting. The purpose of conducting these diagnostic motility studies is to determine if a patient's pain is caused by Sphincter of Oddi Dysfunction, where the contractions of the Sphincter of Oddi are abnormally high and/or erratic. This dysfunction is most commonly found in patients who have already undergone the removal of their gall bladder. Once diagnosed, the main course of treatment is either medication or sphincterotomy.

Source page: https://510kreport.com/device/K120524
Methodology: https://510kreport.com/methodology