510(k) · Cleared
ClearedA-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200
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 Jun 8, 2010 as substantially equivalent to K072593 (Healthstats International Pte., Ltd., 2007) and 3 other predicates after a 57-day review. Its family tree reaches back 5 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 8, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K872291 (1987). 20 ancestors in all, the oldest K855127 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 4 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 3 generations backK013434 VP-2000/1000Colin Corp. · 2002
- 2 generations backK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
- 1 generation backK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- This deviceK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK131788 Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP…Healthstats International Pte., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK121266 CardioscopePulsecor Limited · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −4 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −3 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| −2 | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
| −1 | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
| 0 (this device) | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | Healthstats International Pte., Ltd. | 2010 | — |
| +1 | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management… | Healthstats International Pte., Ltd. | 2014 | — |
| +1 | 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 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareSummary page 1…Product Code: 74 DXN, 21 CFR § 870.1130 Class: Class 11 (3) Predicate Device(s): K072593 HealthSTATS A-Pulse® Arterial Pulse Waveform Analysis System, HealthSTATS International Pte Ltd… | 2007 |
| * | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemSummary page 1…vice(s): K072593 HealthSTATS A-Pulse® Arterial Pulse Waveform Analysis System, HealthSTATS International Pte Ltd K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, H-ealthSTATS International Pte Ltd… | 2006 |
| * | K051546 | Bpcalibrator MC3000/MC3100Summary page 1…Pte Ltd K060315 HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System, H-ealthSTATS International Pte Ltd K051546 HealthSTATS BPCalibrator MC300/MC3100 Blood Pressure Monitor, HealthSTATS International Pte Ltd… | 2005 |
| * | K012487 | Sphygmocor PX Model Scor-PXSummary page 1…l Pte Ltd K051546 HealthSTATS BPCalibrator MC300/MC3100 Blood Pressure Monitor, HealthSTATS International Pte Ltd K01 2487 SphygmoCor PUlse Waveform Analysis System, Atoor Medical Pty Ltd Reason for Submissio… | 2002 |
What descends from it? (2)
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 23 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K131788 (Healthstats International Pte., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072593.
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. 2010, 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-PULSE CASPro/CASPaI Monitors are compact standalone monitors that combine two methods of blood pressure measurement: * Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and * Radial arterial pulse acquisition via a wrist-mounted tonometer sensor. The A-PULSE CASProICASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse…
Read the full statement (191 words)
The A-PULSE CASPro/CASPaI Monitors are compact standalone monitors that combine two methods of blood pressure measurement:
* Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
* Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.
The A-PULSE CASProICASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.
The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a non-volatile memory to store and recall measurements.
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
The A-PULSE CASPro/CASPaI Monitors are intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101002 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101002
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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