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 Oct 7, 2011 as substantially equivalent to K013354 (Cardiocomm Solutions, Inc., 2002) and 2 other predicates after a 150-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Oct 7, 2011
- Review
- 150 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K941811 (1994). 31 ancestors in all, the oldest K822695 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 2 generations backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- 1 generation backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- This deviceK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK162571 Bioflux SoftwareBiotricity, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK201040 Bioflux Software IIBiotricity · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −2 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| −1 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| 0 (this device) | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +1 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +2 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
| +3 | K201040 | Bioflux Software II | Biotricity | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K013354 | GlobalcardioSummary page 2…pret the data. The purpose of this submission is to include the 12 Lead ECU and Digital Device Integration modules. Predicate Device: UlobalCardin (K013354) CardioView 32 Review Module (K083321) Substantial Equivalence: The propos… | 2002 |
| * | K083321 | Cardio-ViewSummary page 2…nd Digital Device Integration modules. Predicate Device: UlobalCardin (K013354) CardioView 32 Review Module (K083321) Substantial Equivalence: The proposed device is substantial equivalent to the GlobalCardio (K03 3037) device. Th… | 2008 |
| * | K033037 | Modification to GlobalcardioSummary page 3…CardioView 32 Review Module (K083321) Substantial Equivalence: The proposed device is substantial equivalent to the GlobalCardio (K03 3037) device. The proposed device has t similar intended use technological, and design characteristics as the predicate devices. Any m… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122632 | Guava II | 2014 | 2 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K122632 (Cardiocomm Solutions, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K013354.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce…
Read the full statement (189 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 to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. GlobalCardio will be accessed over the Internet 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. 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.
https://510kreport.com/device/K111320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111320: Globalcardio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111320
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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