510(k) · Cleared
ClearedMercator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harley Street Software, Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on Jan 27, 1999 as substantially equivalent to K964036 (Instromedix, Inc., 1997) and 2 other predicates after a 203-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Jan 27, 1999
- Review
- 203 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945626 (1995). 4 ancestors in all, the oldest K915632 (1992). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
- 1 generation backK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
- This deviceK982384 MercatorHarley Street Software, Ltd. · 1999
- Descendant · cites it directly · 5 of its ownK013354 GlobalcardioCardiocomm Solutions, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK033037 Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK111320 GlobalcardioCardiocomm Solutions, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK122632 Guava IICardiocomm Solutions, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK162571 Bioflux SoftwareBiotricity, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013354GlobalcardioCardiocomm Solutions, Inc. · 2002 · cites it directly5descendants
- K033037Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003 · 2 generations on4descendants
- K111320GlobalcardioCardiocomm Solutions, Inc. · 2011 · 2 generations on3descendants
- K122632Guava IICardiocomm Solutions, Inc. · 2014 · 3 generations on2descendants
- K162571Bioflux SoftwareBiotricity, Inc. · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945626 | Quinton Model 710 Stress Electrocardiograph | Quinton, Inc. | 1995 | — |
| −1 | K964784 | Synergy Cardiology Information System (00431) | Quinton, Inc. | 1997 | — |
| 0 (this device) | K982384 | Mercator | Harley Street Software, Ltd. | 1999 | — |
| +1 | K013354 | Globalcardio | Cardiocomm Solutions, Inc. | 2002 | — |
| +2 | K033037 | Modification to Globalcardio | Cardiocomm Solutions, Inc. | 2003 | — |
| +2 | K111320 | Globalcardio | Cardiocomm Solutions, Inc. | 2011 | — |
| +3 | K122632 | Guava II | Cardiocomm Solutions, Inc. | 2014 | — |
| +4 | K162571 | Bioflux Software | Biotricity, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964036 | Cardiomagic 2000 SoftwareSummary page 1…ion Names: 870.2340 Electrocardiograph 870.2450 Medical Cathode-Ray Tube Display 870.1425 Programmable Diagnostic Computer Predicate Devices: Cardiomagic Concerto 2000 (K964036) Synergy (K964784) Paceart CPTS-86/12 (K915632) Device Description Mercator is a software product designed for the Microsoft Wi… | 1997 |
| * | K964784 | Synergy Cardiology Information System (00431)Summary page 1…0 Electrocardiograph 870.2450 Medical Cathode-Ray Tube Display 870.1425 Programmable Diagnostic Computer Predicate Devices: Cardiomagic Concerto 2000 (K964036) Synergy (K964784) Paceart CPTS-86/12 (K915632) Device Description Mercator is a software product designed for the Microsoft Windows 95 and Micro… | 1997 |
| * | K915632 | Paceart CPTS-86/12Summary page 1…Medical Cathode-Ray Tube Display 870.1425 Programmable Diagnostic Computer Predicate Devices: Cardiomagic Concerto 2000 (K964036) Synergy (K964784) Paceart CPTS-86/12 (K915632) Device Description Mercator is a software product designed for the Microsoft Windows 95 and Microsoft Windows NT operating sys… | 1992 |
What descends from it? (7)
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 4 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K013354 (Cardiocomm Solutions, Inc., 2002) has gone furthest, with 5 descendants of its own.
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?
Mercator is intended to be used as a data management tool for physicians and cardiac
clinics to store, retrieve, communicate and report ECG and ECG data acquired from a
variety of ECG sources including Holter and Event Recorder 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.
Mercator is intended for use in clinics, hospitals, physician’s offices, or anywhere a
medical doctor deems appropriate. Mercator does not offer diagnosis or medical
alarms.
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/K982384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982384: Mercator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982384
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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