510(k) · Cleared
ClearedAtmo Gas Capsule System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atmo Biosciences, Ltd. · NYV Gastrointestinal Motility System, Capsule
Cleared on May 22, 2026 as substantially equivalent to K250940 (Atmo Biosciences, Ltd., 2025) after a 186-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- May 22, 2026
- Review
- 186 days
- Class
- Class II
- Product code
- NYV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K092342 (2009). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NYV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NYV device
- #1 K250940 Atmo Gas Capsule Systemscore 12.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250940 | Atmo Gas Capsule SystemSummary page 5….1725 Gastrointestinal motility monitoring system Product Code: NYV Capsule Gastrointestinal Motility System Predicate Device(s) Atmo Gas Capsule System (K250940) Predicate Device K250940 510(k) number 2 Device Description The Atmo Gas Capsule System is a prescription onl… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NYV devicesNYV Gastrointestinal Motility System, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NYV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NYV
Too few NYV 510(k)s in any year since 2007 to give a median.
Recalls per year · NYV
No recall names NYV since 2007.
Adverse event reports per year · NYV
1in 2025
MAUDE reports naming product code NYV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (159 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253569: Atmo Gas Capsule System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253569
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026