510(k) · Cleared
ClearedModification to Sphygmocor Cardiovascular Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atcor Medical · DSK Computer, Blood-Pressure
Cleared on Apr 23, 2008 as substantially equivalent to K070795 (Atcor Medical Pty, Ltd., 2007) and 1 other predicate after a 44-day review. Its family tree reaches back 5 generations to 1995. 8 later devices descend from it.
- Decided
- Apr 23, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K950779 (1995). 18 ancestors in all, the oldest K872291 (1987). 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 4 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 3 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 2 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 1 generation backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- This deviceK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008
- Descendant · cites it directly · 6 of its ownK122129 Sphygmocor XcelAtcor Medical · 2012
- Descendant · 2 generations on · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK251581 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K122129Sphygmocor XcelAtcor Medical · 2012 · cites it directly6descendants
- K151520Oscar 2Suntech Medical, Inc. · 2016 · 2 generations on3descendants
- K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc. · 2021 · 3 generations on1descendant
- K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 3 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −4 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −3 | 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 | — |
| 0 (this device) | K080670 | Modification to Sphygmocor Cardiovascular Management System | Atcor Medical | 2008 | — |
| +1 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
| +2 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| +3 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| +3 | K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026 | — |
| +4 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 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 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 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
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 |
|---|---|---|---|
| * | K070795 | Sphygmocor Cardiovascular Management SystemSummary page 1…chometer & rate alarm) Proprietary Name SphygmoCor@ Cardiovascular Management System (CvMS) Predicate Device(s) Primary (un-modified device) - K070795 SphygmoCor Cardiovascular Management System CvMS (AtCor Medical Pty Ltd)… | 2007 |
| * | K013434 | VP-2000/1000Summary page 1…dified device) - K070795 SphygmoCor Cardiovascular Management System CvMS (AtCor Medical Pty Ltd) Secondary - K01 3434 Vascular Profiling System VP-2000 (Colin Corp) Reason for submission Modification to existing product Intended Use… | 2002 |
What descends from it? (8)
2 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 13 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K122129 (Atcor Medical, 2012) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K070795.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DSK
1in 2023
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
MAUDE reports naming product code DSK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 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…
Read the full statement (123 words)
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 HRV measurements in response to controlled exercises.
The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080670 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080670: Modification to Sphygmocor Cardiovascular Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080670
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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