# K984444: Insight Gastrointestinal Motility System, Model S980000

- Pathway: 510(k) (Special)
- Applicant: Sandhill Scientific, Inc.
- Decided: Jan 11, 1999 after 28 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 K821588 (1982). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961056: Bioview Model S960000, Sandhill Scientific, Inc. (1996) Summary page 1.
- K821588: Sandhill DMS, Sandhill (1982) Summary page 1.

## Most influential descendants
- K091070: Manoscan Motility with Impedance Visualization System (2009), 1 descendant of its own
- K151086: ManoScan System (2016), 0 descendants of its own

## Indications for use
The InSIGHT Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal motility and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.

Source page: https://510kreport.com/device/K984444
Methodology: https://510kreport.com/methodology