510(k) · Cleared
ClearedGastric Alimetry System
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 Apr 27, 2023 as substantially equivalent to K213924 (Alimetry, Ltd., 2022) after a 170-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.
- Decided
- Apr 27, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- MYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN990005 (1999). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN990005 The 3PM Egg Machine3pm Co., Inc. · 1999
- 2 generations backK014269 Polygram Net Electrogastrography Application Software, Model…Medtronic Functional Diagnostics A/S · 2002
- 1 generation backK213924 Gastric Alimetry SystemAlimetry, Ltd. · 2022
- This deviceK223398 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK232925 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK240946 Gastric AlimetryAlimetry, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK252504 Gastric AlimetryAlimetry, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK262292 Gastric AlimetryAlimetry, Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K232925Gastric Alimetry SystemAlimetry, Ltd. · 2023 · cites it directly3descendants
- K240946Gastric AlimetryAlimetry, Ltd. · 2024 · 2 generations on2descendants
- K252504Gastric AlimetryAlimetry, Ltd. · 2025 · 3 generations on1descendant
- K262292Gastric AlimetryAlimetry, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN990005 | The 3PM Egg Machine | 3pm Co., Inc. | 1999 | — |
| −2 | K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151… | Medtronic Functional Diagnostics A/S | 2002 | — |
| −1 | K213924 | Gastric Alimetry System | Alimetry, Ltd. | 2022 | — |
| 0 (this device) | K223398 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +1 | K232925 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +2 | K240946 | Gastric Alimetry | Alimetry, Ltd. | 2024 | — |
| +3 | K252504 | Gastric Alimetry | Alimetry, Ltd. | 2025 | — |
| +4 | K262292 | Gastric Alimetry | Alimetry, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K213924 | Gastric Alimetry SystemSummary page 4…me: Electrogastrography system, 21 CFR 876.1735, Product code: MYE Class II Predicate and Reference Devices 1. Trade Name: Gastric Alimetry (K213924) (primary predicate) Manufacturer: Alimetry Ltd. 2. Trade Name: Polygraf ID with POLYGRAM NET ElectroGa… | 2022 |
| † | K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232925 | Gastric Alimetry System | 2023 | 3 |
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 24 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232925 (Alimetry, Ltd., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MYE devicesMYE System, Electrogastrography (Egg): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223398: Gastric Alimetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223398
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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