# K253569: Atmo Gas Capsule System

- Pathway: 510(k) (Traditional)
- Applicant: Atmo Biosciences, Ltd.
- Decided: May 22, 2026 after 186 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: 2 generations back to K092342 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250940: Atmo Gas Capsule System, Atmo Biosciences, Ltd. (2025) Summary page 5.

## 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, carbon dioxide concentration, and contractility frequency, and indicators of oxygen level, Capsule tumble, and antenna reflectance. The device displays a contractility frequency map based on measurements of capsule movement caused by gastrointestinal pressures and contractions. Not for use in pediatric patients.

Source page: https://510kreport.com/device/K253569
Methodology: https://510kreport.com/methodology