510(k) · Cleared
ClearedBPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT 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 Jun 21, 2018 as substantially equivalent to K060315 (Healthstats International Pte., Ltd., 2006) after a 266-day review. Its family tree reaches back 3 generations to 1986. 13 later devices descend from it.
- Decided
- Jun 21, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K855127 (1986). 4 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 2 generations backK031479 Ambulatory Blood Pressure (Abp) 92506 Report Management System…Datex-Ohmeda, Inc. · 2003
- 1 generation backK060315 Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006
- This deviceK173028 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT…Healthstats International Pte., Ltd. · 2018
- Descendant · cites it directly · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK250415 G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · cites it directly12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 2 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 3 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 2 generations on2descendants
- K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −2 | K031479 | Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model… | Datex-Ohmeda, Inc. | 2003 | — |
| −1 | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring System | Healthstats International Pte., Ltd. | 2006 | — |
| 0 (this device) | K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte., Ltd. | 2018 | — |
| +1 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +2 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +3 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +2 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
| +2 | K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemSummary page 4…Product Code: 74 DXN, 21 CFR § 870.1130 Class: Class II (3) Predicate Device(s): K060315 BPro Ambulatory Blood Pressure Monitoring with BProSOft application software Reason… | 2006 |
| † | K131788 | Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application… | 2014 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190792 | BB-613WP | 2019 | 12 |
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 32 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K190792 (Biobeat Technologies, Ltd., 2019) has gone furthest, with 12 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. 2018, 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® BT Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT software, a PC-based computer program. Before each measurement session, the wrist device is calibrated using the…
Read the full statement (174 words)
The BPro® BT Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT software, a PC-based computer program.
Before each measurement session, the wrist 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 and pulse rate over a period of 24 hours.
BProSOft BT 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 a 24-hour period.
The BPro BT system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
The BPro BT system is intended only for measurement, recording, and display. It makes no diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173028: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT 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/K173028
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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