# K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Functional Diagnostics A/S
- Decided: Nov 21, 2002 after 329 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
Longest line of descent: 1 generation back to DEN990005 (1999). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN990005: The 3PM Egg Machine, 3pm Co., Inc. (1999). 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.

## Most influential descendants
- 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
- K252504: Gastric Alimetry (2025), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K014269
Methodology: https://510kreport.com/methodology