510(k) · Cleared

Cleared

G-Tech Wireless Patch System (WPS)

K212954510(k) TraditionalCleared Jan 10, 2022116-day reviewClass II21 CFR 876.1735

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

G-Tech Medical · MYE System, Electrogastrography (Egg)

Cleared on Jan 10, 2022 as substantially equivalent to DEN990005 (3pm Co., Inc., 1999) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jan 10, 2022
Review: 116 days
Class: Class II
Product code: MYE
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to DEN990005 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN990005 The 3PM Egg Machine3pm Co., Inc. · 1999
1 generation backK014269 Polygram Net Electrogastrography Application Software, Model…Medtronic Functional Diagnostics A/S · 2002
This deviceK212954 G-Tech Wireless Patch System (WPS)G-Tech Medical · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN990005	The 3PM Egg Machine	3pm Co., Inc.	1999	—
−1	K014269	Polygram Net Electrogastrography Application Software, Model 9043S0151…	Medtronic Functional Diagnostics A/S	2002	—
0 (this device)	K212954	G-Tech Wireless Patch System (WPS)	G-Tech Medical	2022	—

FIG. 1 — Lineage of K212954, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	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.	3pm Co., Inc.	1999	—
*	K014269	Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID… Summary page 4 …roduct Code: MYE Predicate Primary predicate device #1: DEN990005 / K984637, THE 3CPM EGG Device(s) MACHINE Predicate device #2: K014269, Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf Id, Model 9043G0102…	Medtronic Functional Diagnostics A/S	2002	—
†	K092342	Smartpill GI Monitoring System, Version 2.0	The Smartpill Corporation	2009	—

Also cleared against DEN990005: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 23 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate DEN990005.

How does its category compare?

All MYE devices

MYE System, Electrogastrography (Egg): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MYE

1in 2025

2007high 2 (2022) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	2	—	0
2023	2	—	0
2024	1	—	0
2025	1	—	0
2026	1	—	—

What is it indicated for?

The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K212954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212954: G-Tech Wireless Patch System (WPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212954

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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