# DEN990005: The 3PM Egg Machine

- Pathway: De Novo (Post-NSE)
- Applicant: 3pm Co., Inc.
- Decided: Aug 20, 1999 after 39 days
- Product code: MYE (System, Electrogastrography (Egg))
- Device class: 2
- Regulation: 21 CFR 876.1735
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102 (2002), 7 descendants of its own
- K213924: Gastric Alimetry System (2022), 5 descendants of its own
- K223398: Gastric Alimetry System (2023), 4 descendants of its own
- K232925: Gastric Alimetry System (2023), 3 descendants of its own
- K240946: Gastric Alimetry (2024), 2 descendants of its own

Source page: https://510kreport.com/device/DEN990005
Methodology: https://510kreport.com/methodology