510(k) · Cleared
ClearedSmartpill GI Monitoring System, Version 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Smartpill Corporation · NYV Gastrointestinal Motility System, Capsule
Cleared on Oct 30, 2009 after an 87-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- NYV
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK092342 Smartpill GI Monitoring System, Version 2.0The Smartpill Corporation · 2009
- Descendant · cites it directly · 1 of its ownK250940 Atmo Gas Capsule SystemAtmo Biosciences, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253569 Atmo Gas Capsule SystemAtmo Biosciences, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250493 MotiliCap GI Monitoring SystemAnx Robotica Corporation · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092342 | Smartpill GI Monitoring System, Version 2.0 | The Smartpill Corporation | 2009 | — |
| +1 | K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2025 | — |
| +2 | K253569 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2026 | — |
| +1 | K250493 | MotiliCap GI Monitoring System | Anx Robotica Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 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 K250940 Atmo Gas Capsule Systemscore 12.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | SmartPill GI Monitoring System and pH.p Capsule, version 1.2 Named without a submission number | |
| * | — | Konsyl Sitzmarks Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K250940 (Atmo Biosciences, Ltd., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NYV devicesNYV Gastrointestinal Motility System, Capsule: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (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…
Read the full statement (153 words)
The SmartPill GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.
Gastric transit time (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 and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.
The System measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility-indices.
Not for use in pediatric patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092342: Smartpill GI Monitoring System, Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092342
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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