510(k) Report

510(k) · Cleared

Cleared

Sphygmocor Cardiovascular Management System

K070795510(k) TraditionalCleared Aug 31, 2007162-day reviewClass II21 CFR 870.1110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Atcor Medical Pty, Ltd. · DSK Computer, Blood-Pressure

Cleared on Aug 31, 2007 as substantially equivalent to K012487 (Atcor Medical Pty, Ltd., 2002) and 5 other predicates after a 162-day review. Its family tree reaches back 4 generations to 1995. 16 later devices descend from it.

Decided
Aug 31, 2007
Review
162 days
Class
Class II
Product code
DSK
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K950779 (1995). 8 ancestors in all. 16 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 2 other ancestors1998: 1 other ancestor2008: 2 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2023: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2026: 2 descendants clearedK950779 · Heart Rate Variability Software Option · Spacelabs, Inc. · 1995K972991 · Monitor One NDX · Qmed, Inc. · 1998K991831 · BMT Anscore Health Management System, Model 1.1 · Boston Medical Technologies, Inc. · 1999K993875 · BMT Anscore Health Management System · Boston Medical Technologies, Inc. · 20001995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K993875 · BMT Anscore Health Management System · Boston Medical Technologies, Inc. · 2000K991831 · BMT Anscore Health Management System, Model 1.1 · Boston Medical Technologies, Inc. · 1999K972991 · Monitor One NDX · Qmed, Inc. · 1998K950779 · Heart Rate Variability Software Option · Spacelabs, Inc. · 19950
  1. Root · 4 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
  2. 3 generations backK972991 Monitor One NDXQmed, Inc. · 1998
  3. 2 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
  4. 1 generation backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
  5. This deviceK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
  6. Descendant · cites it directly · 8 of its ownK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
  7. Descendant · cites it directly · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008
  8. Descendant · cites it directly · 6 of its ownK122129 Sphygmocor XcelAtcor Medical · 2012
  9. Descendant · 2 generations on · 5 of its ownK140928 ABPM7100I.E.M. GmbH · 2014
  10. Descendant · 2 generations on · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008: 22010: 12011: 22012: 22014: 22016: 22018: 12021: 12023: 12026: 2
2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all
  • K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011 · cites it directly8descendants
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · cites it directly8descendants
  • K122129Sphygmocor XcelAtcor Medical · 2012 · cites it directly6descendants
  • K140928ABPM7100I.E.M. GmbH · 2014 · 2 generations on5descendants
  • K151520Oscar 2Suntech Medical, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950779Heart Rate Variability Software OptionSpacelabs, Inc.1995—
−3K972991Monitor One NDXQmed, Inc.1998—
−2K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc.1999—
−1K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc.2000—
0 (this device)K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.2007—
+1K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH2011—
+1K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical2008—
+1K122129Sphygmocor XcelAtcor Medical2012—
+2K140928ABPM7100I.E.M. GmbH2014—
+2K151520Oscar 2Suntech Medical, Inc.20162

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201010
201120
201220
201420
201620
201810
202110
202310
202620
FIG. 1 — Lineage of K070795, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DSK? 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 DSK device

  1. #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012487Sphygmocor PX Model Scor-PX
Summary page 1
…Contact: Ross Harricks, CEO C. Legally Marketed Predicate Devices The CvMS is substantially equivalent to the SphygmoCor SCOR-Px (K012487). The CvMS's Heart Rate Variability (HRV) feature is substantially equivalent to: 1. Boston Medical Technologie…
Atcor Medical Pty, Ltd.2002—
*K991831BMT Anscore Health Management System, Model 1.1
Summary page 1
…V) feature is substantially equivalent to: 1. Boston Medical Technologies' "BMT Anscore Health Management System" and its variations (K991831, K993875, and K010955); 2L QMed, Inc.'s "Monitor One NDX" HRV analysis ffinction (K972991I); and…
Boston Medical Technologies, Inc.1999—
*K993875BMT Anscore Health Management System
Summary page 1
…e is substantially equivalent to: 1. Boston Medical Technologies' "BMT Anscore Health Management System" and its variations (K991831, K993875, and K010955); 2L QMed, Inc.'s "Monitor One NDX" HRV analysis ffinction (K972991I); and 3. Spacel…
Boston Medical Technologies, Inc.2000—
*K010955BMT Anscore Health Management System
Summary page 1
…ially equivalent to: 1. Boston Medical Technologies' "BMT Anscore Health Management System" and its variations (K991831, K993875, and K010955); 2L QMed, Inc.'s "Monitor One NDX" HRV analysis ffinction (K972991I); and 3. Spacelabs, Inc.'s "…
Boston Medical Technologies, Inc.2001—
*K972991Monitor One NDX
Summary page 1
…ealth Management System" and its variations (K991831, K993875, and K010955); 2L QMed, Inc.'s "Monitor One NDX" HRV analysis ffinction (K972991I); and 3. Spacelabs, Inc.'s "Heart Rate Variability Software Option" (K950779). B. Device Description The CvMS…
Qmed, Inc.1998—
*K950779Heart Rate Variability Software Option
Summary page 1
…; 2L QMed, Inc.'s "Monitor One NDX" HRV analysis ffinction (K972991I); and 3. Spacelabs, Inc.'s "Heart Rate Variability Software Option" (K950779). B. Device Description The CvMS is a modified version of the SphygmoCor Px (K01 2487). Like its predecessor, the CvMS is a com…
Spacelabs, Inc.1995—

Also cleared against K012487: 5 other devices →

What descends from it? (16)

See all 16

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118
K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088
K122129Sphygmocor XcelAtcor Medical20126
K092809HRV AcquireWr Medical Electronics Co.20100
K081654HEM-9000AIOmron Healthcare, Inc.20080

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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K110603 (I.E.M. GmbH, 2011) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K012487.

How does its category compare?

All DSK devices

DSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DSK

1in 2023

2007: 12008: 12015: 22016: 12023: 1
2007high 2 (2015) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSK

Too few DSK 510(k)s in any year since 2007 to give a median.

Recalls per year · DSK

No recall names DSK since 2007.

Adverse event reports per year · DSK

26in 2025

2010: 102011: 52012: 692013: 52014: 82015: 72016: 132017: 62018: 932019: 1482020: 292021: 312022: 292023: 142024: 122025: 26
2007high 148 (2019) · low 0 (2007)2025

MAUDE reports naming product code DSK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
20100—010
20110—05
20120—069
20130—05
20140—08
20152—07
20161—013
20170—06
20180—093
20190—0148
20200—029
20210—031
20220—029
20231—014
20240—012
20250—026
20260—0—

What is it indicated for?

The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The CvMS heart rate variability (HRV) option is intended for use in obtaining heart rate variability measurements in response to controlled exercises.

Indications for use as stated in the FDA summary.

Also cleared against K012487

5 other devices cite the same predicate.

  • K121266CardioscopePulsecor Limited · 2012
  • K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
  • K081654HEM-9000AIOmron Healthcare, Inc. · 2008
  • K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
  • K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc. · 2005

More from Atcor Medical Pty, Ltd.

2 FDA decisions under this applicant name. See the company

  • K012487Sphygmocor PX Model Scor-PXAtcor Medical Pty, Ltd. · 2002

Recent decisions in DSK

The DSK category page

  • K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC · 2023
  • K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC · 2016
  • K152582CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxVolcano Corporation · 2015
  • K141615Endophys Blood Pressure MonitorEndophys, Inc. · 2015
  • K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008

https://510kreport.com/device/K070795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070795: Sphygmocor Cardiovascular 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/K070795

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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