510(k) · Cleared
ClearedBMT Anscore Health Management System
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 Aug 11, 2000 as substantially equivalent to K991831 (Boston Medical Technologies, Inc., 1999) after a 270-day review. Its family tree reaches back 3 generations to 1995. 17 later devices descend from it.
- Decided
- Aug 11, 2000
- Review
- 270 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950779 (1995). 4 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 2 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 1 generation backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- This deviceK993875 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 · 2 generations on · 6 of its ownK122129 Sphygmocor XcelAtcor Medical · 2012
- Descendant · 3 generations on · 5 of its ownK140928 ABPM7100I.E.M. GmbH · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- 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
- K122129Sphygmocor XcelAtcor Medical · 2012 · 2 generations on6descendants
- K140928ABPM7100I.E.M. GmbH · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −2 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −1 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
| +3 | K140928 | ABPM7100 | I.E.M. GmbH | 2014 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K991831 | BMT Anscore Health Management System, Model 1.1Summary page 1…ctrocardiograph Predicate Device: The Anscore™ Health Management System is substantially equivalent to the previously 510(k)-cleared Anscore™ Health Management System (K991831). Intended Use: The Anscore™ has the same intended use as the legally marketed predicate devices. The Anscore™ sy… | 1999 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070795 | Sphygmocor Cardiovascular Management System | 2007 | 16 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070795 (Atcor Medical Pty, Ltd., 2007) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K991831.
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 Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.
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/K993875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993875: BMT Anscore Health Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993875
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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