510(k) · Cleared
ClearedMonitor One NDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qmed, Inc. · DPS Electrocardiograph
Cleared on Dec 3, 1998 as substantially equivalent to K950779 (Spacelabs, Inc., 1995) after a 478-day review. Its family tree reaches back 1 generation to 1995. 31 later devices descend from it.
- Decided
- Dec 3, 1998
- Review
- 478 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950779 (1995). 31 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- This deviceK972991 Monitor One NDXQmed, Inc. · 1998
- Descendant · cites it directly · 26 of its ownK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 17 of its ownK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- Descendant · 2 generations on · 8 of its ownK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
- Descendant · 2 generations on · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999 · cites it directly26descendants
- K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000 · 2 generations on17descendants
- K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007 · cites it directly16descendants
- K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011 · 2 generations on8descendants
- K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| 0 (this device) | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| +1 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| +2 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| +1 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| +2 | K110603 | Hypertension Management Software Claient Server (HMS-CS) | I.E.M. GmbH | 2011 | — |
| +2 | K080670 | Modification to Sphygmocor Cardiovascular Management System | Atcor Medical | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K950779 | Heart Rate Variability Software OptionSummary page 6…ATE DEVICE For statistical analysis of heart rate variability, the monitor one nDx® is substantially equivalent to the SpaceLabs Heart Rate Variability Software Option (K950779) that was determined to be SE April 25, 1995. nx_sec01.D0OC rev 12/2/98 Author JFH Page6of 7 6. 13:17 51672574… | 1995 |
What descends from it? (31)
See all 314 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?
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 monitor one nDx® is intended to measure time domain heart rate variability (HRV) in response to a series of standardized, controlled exercises on the part of the patient. While the monitor one nDx® has been shown to be safe and effective for the measurement of heart rate variability, it is not intended to be used as the basis for a specific clinical diagnosis. The clinical significance of HRV should be determined by the physician.
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/K972991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972991: Monitor One NDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972991
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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