# K012232: Insight, Model S980000

- Pathway: 510(k) (Traditional)
- Applicant: Sandhill Scientific, Inc.
- Decided: Jun 7, 2002 after 326 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092850: Endoflip (2009), 9 descendants of its own
- K120997: Barostat Software Option (2012), 7 descendants of its own
- K160725: EndoFLIP (2016), 4 descendants of its own
- K183072: EndoFLIP System (2019), 2 descendants of its own
- K142327: smARTrack Feeding Tube System (2015), 2 descendants of its own

## Recalls of this device
- Jul 25, 2023 · Class III · Z-2521-2023: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
- Feb 23, 2009 · Not classified · Z-1487-2012: Software error may produce incorrect esophageal contraction readings.

## Indications for use
The 1nSiglit Model S9SOOOO Gastrointestinal Motility System is intended for use by gastroenterologists, surgcons, and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. Tt may be used for esophageal, biliary>and anorectal motility studies. The system includes analysis software, but rcquircs skilled interpretation by a physician tu make a diagnosis. The Accessory Model MTT, when used in conjunction with a pH probe, can be used as an aid in dif'fertsntiating acid vs. non-acid reflux evcnts. In addition, the Accessory Model MTT is intended to measure motor knction of the proximal gastrointestinal tract including swallow effeGtiveness and directional bolus transport. by means of intraiurninal impedance recording, The Accessory Model h4II component of the TnSight Gastrointestinal Motility System is not intended for use in biliary studies.

Source page: https://510kreport.com/device/K012232
Methodology: https://510kreport.com/methodology