510(k) · Cleared
ClearedSphygmocor PX Model Scor-PX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atcor Medical Pty, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 21, 2002 as substantially equivalent to K002742 (Pwv Medical Pty, Lt., 2001) after a 203-day review. Its family tree reaches back 1 generation to 2001. 21 later devices descend from it.
- Decided
- Feb 21, 2002
- Review
- 203 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002742 (2001). 21 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK002742 Sphygmocor MX Model Scor-MXPwv Medical Pty, Lt. · 2001
- This deviceK012487 Sphygmocor PX Model Scor-PXAtcor Medical Pty, Ltd. · 2002
- 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 · cites it directly · 6 of its ownK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · 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
- K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc. · 2005 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002742 | Sphygmocor MX Model Scor-MX | Pwv Medical Pty, Lt. | 2001 | — |
| 0 (this device) | K012487 | Sphygmocor PX Model Scor-PX | Atcor Medical Pty, Ltd. | 2002 | — |
| +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 | — |
| +1 | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K002742 | Sphygmocor MX Model Scor-MXSummary page 1…W 2114 Australia Contact: Ross Harricks, CEO A. Legally Marketed Predicate Devices The SphygmoCor SCOR-Px is substantially equivalent to the SphygmoCor Mx cleared under K002742. Both systems have the same intended use, which is to provide the calibrated central aortic pressure waveform. Device Descriptio… | 2001 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070795 | Sphygmocor Cardiovascular Management System | 2007 | 16 |
| K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI | 2005 | 6 |
| K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | 2007 | 4 |
| K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | 2010 | 2 |
| K121266 | Cardioscope | 2012 | 0 |
| K081654 | HEM-9000AI | 2008 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K070795 (Atcor Medical Pty, Ltd., 2007) has gone furthest, with 16 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.
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/K012487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012487: Sphygmocor PX Model Scor-PX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012487
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026