510(k) · Cleared
ClearedGlobalcardio
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 Jan 31, 2002 as substantially equivalent to K982384 (Harley Street Software, Ltd., 1999) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 31, 2002
- Review
- 114 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945626 (1995). 6 ancestors in all, the oldest K915632 (1992). 5 later devices descend from it, 2 citing it directly.
- 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 deviceK013354 GlobalcardioCardiocomm Solutions, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK033037 Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK201040 Bioflux Software IIBiotricity · 2020
Most influential descendants
Showing 5 of 5 · See all- K033037Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003 · cites it directly4descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · cites it directly3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 2 generations on2descendants
- K162571Bioflux SoftwareBiotricity, Inc. · 2016 · 3 generations on1descendant
- K201040Bioflux Software IIBiotricity · 2020 · 4 generations on0descendants
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) | K013354 | Globalcardio | Cardiocomm Solutions, Inc. | 2002 | — |
| +1 | K033037 | Modification to Globalcardio | Cardiocomm Solutions, Inc. | 2003 | — |
| +1 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +2 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +3 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
| +4 | K201040 | Bioflux Software II | Biotricity | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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…h the requirements of SMDA 1990 and 21 CFR 807.92.. The assigned 510(k) number is: K013354. Device Name: GlobalCardio Substantial Equivalence is claimed to; Mercator (K982384) Brentwood PC-ECG (K955023) Description: GlobalCardio is a cardiology software produbt, delivered over the web using the Applic… | 1999 |
| * | K955023 | Brentwood PC-EcgSummary page 1…1990 and 21 CFR 807.92.. The assigned 510(k) number is: K013354. Device Name: GlobalCardio Substantial Equivalence is claimed to; Mercator (K982384) Brentwood PC-ECG (K955023) Description: GlobalCardio is a cardiology software produbt, delivered over the web using the Application Service Provider (ASP… | 1997 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 ancestors has a recall of any class.
- Of its descendants, K033037 (Cardiocomm Solutions, Inc., 2003) has gone furthest, with 4 descendants of its own.
- 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?
GlobalCardio 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 {0 store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the Intenet and data will be stored at either the…
Read the full statement (164 words)
GlobalCardio 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 {0 store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the Intenet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will'be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. GlobalCardio is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. |t 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.
https://510kreport.com/device/K013354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013354: Globalcardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013354
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026