De Novo · Granted
GrantedThe 3PM Egg Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3pm Co., Inc. · MYE System, Electrogastrography (Egg)
Granted on Aug 20, 1999 as a new device type through De Novo after a 39-day review. 9 later devices descend from it.
- Decided
- Aug 20, 1999
- Review
- 39 days
- Class
- Class II
- Product code
- MYE
- Recalls
- None
9 later devices descend from it, 3 citing it directly.
- This deviceDEN990005 The 3PM Egg Machine3pm Co., Inc. · 1999
- Descendant · cites it directly · 7 of its ownK014269 Polygram Net Electrogastrography Application Software, Model…Medtronic Functional Diagnostics A/S · 2002
- Descendant · 2 generations on · 5 of its ownK213924 Gastric Alimetry SystemAlimetry, Ltd. · 2022
- Descendant · 3 generations on · 4 of its ownK223398 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · 4 generations on · 3 of its ownK232925 Gastric Alimetry SystemAlimetry, Ltd. · 2023
- Descendant · 5 generations on · 2 of its ownK240946 Gastric AlimetryAlimetry, Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K014269Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID…Medtronic Functional Diagnostics A/S · 2002 · cites it directly7descendants
- K213924Gastric Alimetry SystemAlimetry, Ltd. · 2022 · 2 generations on5descendants
- K223398Gastric Alimetry SystemAlimetry, Ltd. · 2023 · 3 generations on4descendants
- K232925Gastric Alimetry SystemAlimetry, Ltd. · 2023 · 4 generations on3descendants
- K240946Gastric AlimetryAlimetry, Ltd. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN990005 | The 3PM Egg Machine | 3pm Co., Inc. | 1999 | — |
| +1 | K014269 | Polygram Net Electrogastrography Application Software, Model 9043S0151… | Medtronic Functional Diagnostics A/S | 2002 | — |
| +2 | K213924 | Gastric Alimetry System | Alimetry, Ltd. | 2022 | — |
| +3 | K223398 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +4 | K232925 | Gastric Alimetry System | Alimetry, Ltd. | 2023 | — |
| +5 | K240946 | Gastric Alimetry | Alimetry, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (9)
3 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, K014269 (Medtronic Functional Diagnostics A/S, 2002) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/DEN990005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN990005: The 3PM Egg Machine.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN990005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026