510(k) · Cleared
ClearedA-Plus Arterial Pulse Waveform Analysis System and PC Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthstats International Pte., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 15, 2007 as substantially equivalent to K060315 (Healthstats International Pte., Ltd., 2006) and 2 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 15, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K872291 (1987). 17 ancestors in all, the oldest K855127 (1986). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 3 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 2 generations backK013434 VP-2000/1000Colin Corp. · 2002
- 1 generation backK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
- This deviceK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK131916 Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK131788 Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP…Healthstats International Pte., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK121266 CardioscopePulsecor Limited · 2012
Most influential descendants
Showing 4 of 4 · See all- K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010 · cites it directly2descendants
- K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd. · 2014 · cites it directly0descendants
- K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd. · 2014 · 2 generations on0descendants
- K121266CardioscopePulsecor Limited · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −3 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −2 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| −1 | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
| 0 (this device) | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
| +1 | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | Healthstats International Pte., Ltd. | 2010 | — |
| +1 | K131916 | Bprosoft Casp PC Software | Healthstats International Pte., Ltd. | 2014 | — |
| +2 | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management… | Healthstats International Pte., Ltd. | 2014 | — |
| +2 | K121266 | Cardioscope | Pulsecor Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemSummary page 1…Product Code: 74 DXN, 21 CFR § 870.1130 Class: Class II (3) Predicate Device(s): K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, HealthSTATS International Pte Ltd… | 2006 |
| * | K012487 | Sphygmocor PX Model Scor-PXSummary page 1…Device(s): K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, HealthSTATS International Pte Ltd K012487 SphygmoCor Pulse Waveform Analysis System, AtCor Medical Pty Ltd K050233 Omron HE… | 2002 |
| * | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AISummary page 1…System, HealthSTATS International Pte Ltd K012487 SphygmoCor Pulse Waveform Analysis System, AtCor Medical Pty Ltd K050233 Omron HEM 9000AI Non-invasive Blood Pressure Monitor with Augmentation Index, Omron Healthcare Inc… | 2005 |
What descends from it? (4)
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 20 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K101002 (Healthstats International Pte., Ltd., 2010) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060315.
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. 2007, this device’s year, is highlighted.
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 A-PulseTM Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor. A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery. Before each measurement session, the…
Read the full statement (158 words)
The A-PulseTM Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor.
A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery.
Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.
A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAI), and a range of other indices.
A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072593
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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