510(k) · Cleared
ClearedHealthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application 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 Mar 4, 2014 as substantially equivalent to K101002 (Healthstats International Pte., Ltd., 2010) and 2 other predicates after a 259-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Mar 4, 2014
- Review
- 259 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K872291 (1987). 23 ancestors in all, the oldest K855127 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 5 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 4 generations backK013434 VP-2000/1000Colin Corp. · 2002
- 3 generations backK050233 Omron Non-Invasive Blood Pressure Monitor with Augmentation Index…Omron Healthcare, Inc. · 2005
- 2 generations backK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- 1 generation backK101002 A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd. · 2010
- This deviceK131788 Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP…Healthstats International Pte., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −5 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −4 | K013434 | VP-2000/1000 | Colin Corp. | 2002 | — |
| −3 | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model… | Omron Healthcare, Inc. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management… | Healthstats International Pte., Ltd. | 2014 | — |
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 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Summary page 1…Product Code: 74 DXN, 21 CFR § 870.1130 Class: Class 11 (3) Predicate Device(s): K1 01 002 HealthSTATS A-PULSE CASPaI® , HealthSTATS International Pte Ltd. K040371 A&D Medi… | 2010 |
| * | K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorSummary page 1…ss 11 (3) Predicate Device(s): K1 01 002 HealthSTATS A-PULSE CASPaI® , HealthSTATS International Pte Ltd. K040371 A&D Medical UA767BT Blood pressure monitor, A&D Engineering, Inc. K061822 Omron… | 2004 |
| * | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3Summary page 1…International Pte Ltd. K040371 A&D Medical UA767BT Blood pressure monitor, A&D Engineering, Inc. K061822 Omron Health Management Software (accessory PC software to Omron HEM-780, Omron Healthcare Ltd.… | 2006 |
| † | K041546 | Digital Fundus Camera, Model CF-60DSI | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 23 ancestors has a recall.
- 1 other device also cites its predicate K101002.
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. 2014, 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 CASPaI+ Monitor is a compact standalone monitor that combines 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 CASPaI+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform…
Read the full statement (223 words)
The A-PULSE CASPaI+ Monitor is a compact standalone monitor that combines 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 CASPaI+ Monitor first measures systolic and diastolic blood pressure and pulse rate using the oscillometric method, and then acquires the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.
The MC3100+ monitor measures systolic and diastolic blood pressure and pulse rate via the oscillometric method via a brachial cuff at the upper arm.
The monitors have a non-volatile memory to store and recall measurements, and the ability to transfer measurement data via Bluetooth wireless communications to other suitably equipped electronic devices, such as a PC with Health STATS. my-BP PC software.
my-BP PC software is used in conjunction with the HealthSTATS A-PULSE CASPaI+ and MC3100+ Monitors to store and display blood pressure data obtained from the monitors.
The A-PULSE CASPaI+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPaI+, have a palpable radial pulse.
Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPaI+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131788
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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