510(k) · Cleared
ClearedSphygmocor MX Model Scor-MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pwv Medical Pty, Lt. · DSK Computer, Blood-Pressure
Cleared on May 1, 2001 after a 242-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- May 1, 2001
- Review
- 242 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 1 citing it directly.
- This deviceK002742 Sphygmocor MX Model Scor-MXPwv Medical Pty, Lt. · 2001
- Descendant · cites it directly · 21 of its ownK012487 Sphygmocor PX Model Scor-PXAtcor Medical Pty, Ltd. · 2002
- Descendant · 2 generations on · 16 of its ownK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- Descendant · 3 generations on · 8 of its ownK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
- Descendant · 3 generations on · 8 of its ownK080670 Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008
- Descendant · 3 generations on · 6 of its ownK122129 Sphygmocor XcelAtcor Medical · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K012487Sphygmocor PX Model Scor-PXAtcor Medical Pty, Ltd. · 2002 · cites it directly21descendants
- K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007 · 2 generations on16descendants
- K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011 · 3 generations on8descendants
- K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical · 2008 · 3 generations on8descendants
- K122129Sphygmocor XcelAtcor Medical · 2012 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002742 | Sphygmocor MX Model Scor-MX | Pwv Medical Pty, Lt. | 2001 | — |
| +1 | K012487 | Sphygmocor PX Model Scor-PX | Atcor Medical Pty, Ltd. | 2002 | — |
| +2 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| +3 | K110603 | Hypertension Management Software Claient Server (HMS-CS) | I.E.M. GmbH | 2011 | — |
| +3 | K080670 | Modification to Sphygmocor Cardiovascular Management System | Atcor Medical | 2008 | — |
| +3 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012487 | Sphygmocor PX Model Scor-PX | 2002 | 21 |
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?
- Of its descendants, K012487 (Atcor Medical Pty, Ltd., 2002) has gone furthest, with 21 descendants of its own.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002742: Sphygmocor MX Model Scor-MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002742
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026