510(k) · Cleared
ClearedPolygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Functional Diagnostics A/S · MYE System, Electrogastrography (Egg)
Cleared on Nov 21, 2002 as substantially equivalent to DEN990005 (3pm Co., Inc., 1999) after a 329-day review. Its family tree reaches back 1 generation to 1999. 7 later devices descend from it.
- Decided
- Nov 21, 2002
- Review
- 329 days
- Class
- Class II
- Product code
- MYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN990005 (1999). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN990005 The 3PM Egg Machine3pm Co., Inc. · 1999
- This deviceK014269 Polygram Net Electrogastrography Application Software, Model…Medtronic Functional Diagnostics A/S · 2002
- Descendant · cites it directly · 5 of its ownK213924 Gastric Alimetry SystemAlimetry, Ltd. · 2022
- Descendant · 2 generations on · 4 of its ownK223398 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · 3 generations on · 3 of its ownK232925 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK240946 Gastric AlimetryAlimetry, Ltd. · 2024
- Descendant · 5 generations on · 1 of its ownK252504 Gastric AlimetryAlimetry, Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213924Gastric Alimetry SystemAlimetry, Ltd. · 2022 · cites it directly5descendants
- K223398Gastric Alimetry SystemAlimetry, Ltd. · 2023 · 2 generations on4descendants
- K232925Gastric Alimetry SystemAlimetry, Ltd. · 2023 · 3 generations on3descendants
- K240946Gastric AlimetryAlimetry, Ltd. · 2024 · 4 generations on2descendants
- K252504Gastric AlimetryAlimetry, Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN990005 | The 3PM Egg Machine | 3pm Co., Inc. | 1999 | — |
| 0 (this device) | K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151… | Medtronic Functional Diagnostics A/S | 2002 | — |
| +1 | K213924 | Gastric Alimetry System | Alimetry, Ltd. | 2022 | — |
| +2 | K223398 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +3 | K232925 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +4 | K240946 | Gastric Alimetry | Alimetry, Ltd. | 2024 | — |
| +5 | K252504 | Gastric Alimetry | Alimetry, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | DEN990005 | The 3PM Egg Machine Our reading of the summary gave K984637, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990005, The 3PM Egg Machine (3pm Co., Inc.), granted Aug 20, 1999; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 1999 |
What descends from it? (7)
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?
How does its category compare?
All MYE devicesMYE System, Electrogastrography (Egg): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PolygrafID with POLYGRAM NETTMElectroGastroGraphy Application is intended
to record, store, process and view gastric myoelectrical activity as an aid in the
diagnosis of gastrointestinal motility disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014269 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014269
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026