# K092342: Smartpill GI Monitoring System, Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: The Smartpill Corporation
- Decided: Oct 30, 2009 after 87 days
- Product code: NYV (Gastrointestinal Motility System, Capsule)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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) SmartPill GI Monitoring System and pH.p Capsule, version 1.2: named in the summary without a submission number
- (no number) Konsyl Sitzmarks: named in the summary without a submission number

## Most influential descendants
- K250940: Atmo Gas Capsule System (2025), 1 descendant of its own
- K253569: Atmo Gas Capsule System (2026), 0 descendants of its own
- K250493: MotiliCap GI Monitoring System (2025), 0 descendants of its own

## Indications for use
The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility-indices. Not for use in pediatric patients.

Source page: https://510kreport.com/device/K092342
Methodology: https://510kreport.com/methodology