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 Jun 26, 2025 as substantially equivalent to K092342 (The Smartpill Corporation, 2009) after a 90-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Jun 26, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- NYV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092342 (2009). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253569Atmo Gas Capsule SystemAtmo Biosciences, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092342 | Smartpill GI Monitoring System, Version 2.0 | The Smartpill Corporation | 2009 | — |
| 0 (this device) | K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2025 | — |
| +1 | K253569 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K253569 Atmo Gas Capsule Systemscore 11.7 · 2 generations · 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 |
|---|---|---|---|
| * | K092342 | Smartpill GI Monitoring System, Version 2.0Summary page 5…em Product Code: NYV Capsule Gastrointestinal Motility System Predicate Device(s) SmartPill GI Monitoring System, version 2.0 Predicate Device K092342 510(k) number 2 Device Description The Atmo Gas Capsule System is a prescription only ingestible telemetric medical de… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253569 | Atmo Gas Capsule System | 2026 | 0 |
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?
How does its category compare?
All NYV devicesNYV Gastrointestinal Motility System, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 (138 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, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance.
Not for use in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250940: 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/K250940
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026