# K053547: Smartpill GI Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: The Smartpill Corporation
- Decided: Jul 18, 2006 after 210 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.
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) Heidelberg pH Capsule: named in the summary without a submission number
- (no number) Heidelberg Gold Medallion Gastro-intestinal pH Measurement System: named in the summary without a submission number
- (no number) Unisensor UniTip Gastrointestinal Pressure Catheter: named in the summary without a submission number

## Indications for use
The SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis). The SmartPill GI Monitoring System measures pH, pressure and temperature throughout the gastrointestinal tract. These physiological measurements are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). In addition, pressure contraction patterns from the antrum and duodenum are used to calculate motility indices. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Not for use in pediatric populations

Source page: https://510kreport.com/device/K053547
Methodology: https://510kreport.com/methodology