# K990441: Insight Sphincter of Oddi Manometry Module, Model S981300

- Pathway: 510(k) (Traditional)
- Applicant: Sandhill Scientific, Inc.
- Decided: May 12, 1999 after 90 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 K900058 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932306: Microinfusor, Sandhill Scientific, Inc. (1994) Summary page 2.
- K900058: Wilson-Cook Biliary Motility Catheter, Wilson-Cook Medical, Inc. (1990) Summary page 2.
- (no number) Hewlett-Packard Model 7788-A: named in the summary without a submission number

## Indications for use
The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

Source page: https://510kreport.com/device/K990441
Methodology: https://510kreport.com/methodology