# K250940: Atmo Gas Capsule System

- Pathway: 510(k) (Traditional)
- Applicant: Atmo Biosciences, Ltd.
- Decided: Jun 26, 2025 after 90 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
Longest line of descent: 1 generation back to K092342 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092342: Smartpill GI Monitoring System, Version 2.0, The Smartpill Corporation (2009) Summary page 5.

## Most influential descendants
- K253569: Atmo Gas Capsule System (2026), 0 descendants of its own

## Indications for use
The Atmo® Gas Capsule System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal transit times are used for evaluating motility disorders. 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, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined, the system will report combined Small and Large Bowel Transit Time (SLBTT). Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance. Not for use in pediatric patients.

Source page: https://510kreport.com/device/K250940
Methodology: https://510kreport.com/methodology