510(k) · Cleared
ClearedGlobal Ecg Management System (Gems)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocomm Solutions, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Sep 27, 2002 as substantially equivalent to K982384 (Harley Street Software, Ltd., 1999) and 1 other predicate after a 73-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Sep 27, 2002
- Review
- 73 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945626 (1995). 7 ancestors in all, the oldest K915632 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
- 2 generations backK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
- 1 generation backK982384 MercatorHarley Street Software, Ltd. · 1999
- This deviceK022297 Global Ecg Management System (Gems)Cardiocomm Solutions, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945626 | Quinton Model 710 Stress Electrocardiograph | Quinton, Inc. | 1995 | — |
| −2 | K964784 | Synergy Cardiology Information System (00431) | Quinton, Inc. | 1997 | — |
| −1 | K982384 | Mercator | Harley Street Software, Ltd. | 1999 | — |
| 0 (this device) | K022297 | Global Ecg Management System (Gems) | Cardiocomm Solutions, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K982384 | MercatorSummary page 1…(250) 744-1866 Contact: Angela Halwas Date: July 15, 2002 Device Name: Global ECG Management System (GEMS) Substantial Equivalence is claimed to: GEMS (K982384 and K020366) Description (;EMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating s… | 1999 |
| * | K020366 | Global Ecg Management System (Gems)Summary page 1…-1866 Contact: Angela Halwas Date: July 15, 2002 Device Name: Global ECG Management System (GEMS) Substantial Equivalence is claimed to: GEMS (K982384 and K020366) Description (;EMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems runni… | 2002 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K982384.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
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 (253 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.
This version of GEMS includes the EASl algorithm far deriving an approximation to a 72-lead ECG from a 3-chann,el recording (using the lead placement specified in the EASlTrak 12 Model 4100 I Zyrned Model 4100 / EASl Arrhythmia Event Monitor user manual). If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications:
Ages: 33 to 82 years
Heights: 147 to 185 cm (58 to 73 in)
Weights: 53 to 'I18 kg (1 17 to 261 Ib)
Height to Weight ratios: 1.41 to 2.99 crnlkg (0.25 to 0.54 inllb)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022297: Global Ecg Management System (Gems).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022297
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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