510(k) · Cleared
ClearedMars Unity Workstation with Heart Rate Variability (HRV) Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · DPS Electrocardiograph
Cleared on Nov 18, 1999 as substantially equivalent to K922171 (Marquette Electronics, Inc., 1992) and 1 other predicate after a 177-day review. Its family tree reaches back 1 generation to 1992. 64 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 177 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922171 (1992). 2 ancestors in all. 64 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
- This deviceK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
- Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- Descendant · 3 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K042108Vista PlusNovacor · 2005 · cites it directly46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants
- K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922171 | Centra II Analysis System | Marquette Electronics, Inc. | 1992 | — |
| 0 (this device) | K991786 | Mars Unity Workstation with Heart Rate Variability (HRV) Option | General Electric Medical Systems Information Techn | 1999 | — |
| +1 | K042108 | Vista Plus | Novacor | 2005 | — |
| +2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +2 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +3 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| +3 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 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 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K922171 | Centra II Analysis SystemSummary page 1…Unity Workstation with Heart Rate Variability (HRV) Option Holter Andalysis System Classification Name: Computer, Diagnostic, Programmable Classification Number: 74DQK K922171 CENTRA Il Analysis System K950779 Spacelabs Heart Rate Variability Software Option The Multi-Parameter Analysis and Review Syste… | 1992 |
| * | K950779 | Heart Rate Variability Software OptionSummary page 1…Variability (HRV) Option Holter Andalysis System Classification Name: Computer, Diagnostic, Programmable Classification Number: 74DQK K922171 CENTRA Il Analysis System K950779 Spacelabs Heart Rate Variability Software Option The Multi-Parameter Analysis and Review System (MARS) unity workstationyis an o… | 1995 |
What descends from it? (64)
See all 646 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K042108 (Novacor, 2005) has gone furthest, with 46 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and mulfiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric. The Heart Rate Variability (HRV) Option is intended to be used for the…
Read the full statement (176 words)
The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and mulfiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric.
The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data.
Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The HRV measurements produced by Heart Rate Variability (HRV} Option are intended to be used by quadlified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgement.
The HRYV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.
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/K991786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991786
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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