510(k) · Cleared
ClearedBprosoft Casp 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 Mar 11, 2014 as substantially equivalent to K060315 (Healthstats International Pte., Ltd., 2006) and 2 other predicates after a 258-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 11, 2014
- Review
- 258 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K950779 (1995). 28 ancestors in all, the oldest K855127 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 5 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 4 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 3 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 2 generations backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- 1 generation backK110603 Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH · 2011
- This deviceK131916 Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −5 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −4 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| −3 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| −2 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| −1 | K110603 | Hypertension Management Software Claient Server (HMS-CS) | I.E.M. GmbH | 2011 | — |
| 0 (this device) | K131916 | Bprosoft Casp PC Software | Healthstats International Pte., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 11 (3) Predicate Device(s): K060315 BPro Ambulatory Blood Pressure Monitoring with BProSOft application software K072593… | 2006 |
| * | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareSummary page 1…(3) Predicate Device(s): K060315 BPro Ambulatory Blood Pressure Monitoring with BProSOft application software K072593 A-PULSE CASIP PC application software - Central Aortic Systolic System K110603… | 2007 |
| * | K110603 | Hypertension Management Software Claient Server (HMS-CS)Summary page 1…application software K072593 A-PULSE CASIP PC application software - Central Aortic Systolic System K110603 Mobil-O-Graph 24h PWA with Hypertension Management Software Client Server (HMS-CS 4.3)… | 2011 |
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 19 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- None of the 28 ancestors has a recall.
- 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. 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 BPro®) system is a noninvasive ambulatory central blood pressure monitoring system based on tonometry at the radial artery of the wrist. The system consists of a BPro® wrist-mounted tonometric monitor, and a BPCalibrator MC3000OM oscillometric blood pressure monitor for calibration, and BProSOft CASPO Software, a PC-based computer program. Before each measurement session, the wrist-mounted tonometric device is calibrated using the oscillometric…
Read the full statement (208 words)
The BPro®) system is a noninvasive ambulatory central blood pressure monitoring system based on tonometry at the radial artery of the wrist. The system consists of a BPro® wrist-mounted tonometric monitor, and a BPCalibrator MC3000OM oscillometric blood pressure monitor for calibration, and BProSOft CASPO Software, a PC-based computer program.
Before each measurement session, the wrist-mounted tonometric device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure, pulse rate, and radial pulse waveform over a 24-hour period. The central aortic systolic pressure (CASP) is calculated utilizing the recorded radial pulse waveform and BProSOft CASPO PC software.
BProSOft GASPO PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to 24-hour period.
The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.
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/K131916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131916: Bprosoft Casp PC Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131916
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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