510(k) · Cleared
ClearedGastric Alimetry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alimetry, Ltd. · MYE System, Electrogastrography (Egg)
Cleared on Sep 4, 2026 as substantially equivalent to K252504 (Alimetry, Ltd., 2025) after a 59-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Sep 4, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- MYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN990005 (1999). No later device cites it as a predicate yet.
- Root · 7 generations backDEN990005 The 3PM Egg Machine3pm Co., Inc. · 1999
- 6 generations backK014269 Polygram Net Electrogastrography Application Software, Model…Medtronic Functional Diagnostics A/S · 2002
- 5 generations backK213924 Gastric Alimetry SystemAlimetry, Ltd. · 2022
- 4 generations backK223398 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- 3 generations backK232925 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- 2 generations backK240946 Gastric AlimetryAlimetry, Ltd. · 2024
- 1 generation backK252504 Gastric AlimetryAlimetry, Ltd. · 2025
- This deviceK262292 Gastric AlimetryAlimetry, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN990005 | The 3PM Egg Machine | 3pm Co., Inc. | 1999 | — |
| −6 | K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151… | Medtronic Functional Diagnostics A/S | 2002 | — |
| −5 | K213924 | Gastric Alimetry System | Alimetry, Ltd. | 2022 | — |
| −4 | K223398 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| −3 | K232925 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| −2 | K240946 | Gastric Alimetry | Alimetry, Ltd. | 2024 | — |
| −1 | K252504 | Gastric Alimetry | Alimetry, Ltd. | 2025 | — |
| 0 (this device) | K262292 | Gastric Alimetry | Alimetry, Ltd. | 2026 | — |
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 MYE? 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 MYE device
- #1 K252504 Gastric Alimetryscore 15.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K252504 | Gastric AlimetrySummary page 5…ystem Classification Name: Electrogastrography system, 21 CFR 876.1735 Regulatory Class: Class II Product Code: MYE Predicate Devices Trade Name: Gastric Alimetry (K252504) (primary predicate) Manufacturer: Alimetry Ltd. Device Description The Gastric Alimetry System is an electrogastrography (EG… | 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 27 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All MYE devicesMYE System, Electrogastrography (Egg): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MYE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYE
Too few MYE 510(k)s in any year since 2007 to give a median.
Recalls per year · MYE
No recall names MYE since 2007.
Adverse event reports per year · MYE
No MAUDE report names MYE since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
The Gastric Alimetry System is indicated for patients 12 years and older.
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/K262292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262292: Gastric Alimetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262292
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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