510(k) Report

510(k) · Cleared

Cleared

Global Ecg Management System (Gems)

K020366510(k) TraditionalCleared Apr 30, 200285-day reviewClass II21 CFR 870.2340

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

Cardiocomm Solutions, Inc. · DPS Electrocardiograph

Cleared on Apr 30, 2002 as substantially equivalent to K955023 (Brentwood Medical Products, Inc., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided
Apr 30, 2002
Review
85 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K955023 (1997). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant clearedK955023 · Brentwood PC-Ecg · Brentwood Medical Products, Inc. · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K955023 · Brentwood PC-Ecg · Brentwood Medical Products, Inc. · 1997 · recalled0
  1. Root · 1 generation backK955023 Brentwood PC-EcgBrentwood Medical Products, Inc. · 1997 · Recalled
  2. This deviceK020366 Global Ecg Management System (Gems)Cardiocomm Solutions, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK022297 Global Ecg Management System (Gems)Cardiocomm Solutions, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955023Brentwood PC-EcgBrentwood Medical Products, Inc.19973
0 (this device)K020366Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.2002—
+1K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K020366, 1997–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K955023Brentwood PC-Ecg
Summary page 1
…21 CFR 807.92. The assigned 510(k) number is: K982384. Device Name: Global ECG Management System Il (GEMS) Substantial Equivalence is claimed to: Brentwood PC-ECG (K955023) Description: GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems runn…
Brentwood Medical Products, Inc.19973

Also cleared against K955023: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022297Global Ecg Management System (Gems)Cardiocomm Solutions, Inc.20020

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?

  • Its one ancestor has a recall.
  • Of its descendants, K022297 (Cardiocomm Solutions, Inc., 2002) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K955023.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for…

Read the full statement (153 words)

GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients’ needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

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

Also cleared against K955023

3 other devices cite the same predicate.

  • K103640Midmark IqecgBrentwood Medical Technology Corp. · 20111 recall
  • K093339Eli PC ElectrocardiographMortara Instrument, Inc. · 20101 recall
  • K013354GlobalcardioCardiocomm Solutions, Inc. · 2002

More from Cardiocomm Solutions, Inc.

9 FDA decisions under this applicant name. See the company

  • K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc. · 2019
  • K122632Guava IICardiocomm Solutions, Inc. · 2014
  • K121009Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc. · 2012
  • K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
  • K111320GlobalcardioCardiocomm Solutions, Inc. · 2011

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https://510kreport.com/device/K020366 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020366: Global Ecg Management System (Gems).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020366

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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