510(k) · Cleared
ClearedBMT Anscore Health Management System, Model 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Technologies, Inc. · DPS Electrocardiograph
Cleared on Jun 11, 1999 as substantially equivalent to K972991 (Qmed, Inc., 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1995. 26 later devices descend from it.
- Decided
- Jun 11, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950779 (1995). 3 ancestors in all. 26 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 1 generation backK972991 Monitor One NDXQmed, Inc. · 1998
- This deviceK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 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
- Descendant · cites it directly · 7 of its ownK071168 The Portable AnsiscopeDyansys, Inc. · 2007
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000 · cites it directly17descendants
- 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
- K071168The Portable AnsiscopeDyansys, Inc. · 2007 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −1 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| 0 (this device) | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| +1 | 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 | — |
| +1 | K071168 | The Portable Ansiscope | Dyansys, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K972991 | Monitor One NDXSummary page 1…ssification Name 870.2340 74 DPS,IT Electrocardiograph 3. The ANScore™ System is substantially equivalent to the following predicate devices: The gmed monitor one nDx (K972991), and the D.E. Hokanson, Inc. ANS2000 (K973426). 4, The ANScore™ System is a cart-based system with a computer-based user inter… | 1998 |
| * | K973426 | Ans 2000 Ecg Monitor and Respiration PacerSummary page 1…iograph 3. The ANScore™ System is substantially equivalent to the following predicate devices: The gmed monitor one nDx (K972991), and the D.E. Hokanson, Inc. ANS2000 (K973426). 4, The ANScore™ System is a cart-based system with a computer-based user interface and data acquisition system for testing, d… | 1998 |
What descends from it? (26)
See all 263 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 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K993875 (Boston Medical Technologies, Inc., 2000) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K972991.
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?
Indications: The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment
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/K991831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991831: BMT Anscore Health Management System, Model 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991831
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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