510(k) · Cleared
ClearedHealthstats Bpro Ambulatory Blood Pressure Monitoring System
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 Apr 7, 2006 as substantially equivalent to K900247 (Colin Medical Instruments Corp., 1990) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1986. 19 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K855127 (1986). 3 ancestors in all. 19 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
- 1 generation backK031479 Ambulatory Blood Pressure (Abp) 92506 Report Management System…Datex-Ohmeda, Inc. · 2003
- This deviceK060315 Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006
- Descendant · cites it directly · 13 of its ownK173028 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT…Healthstats International Pte., Ltd. · 2018
- Descendant · 2 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · cites it directly · 4 of its ownK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
- Descendant · 4 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareHealthstats International Pte., Ltd. · 2018 · cites it directly13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 2 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 3 generations on5descendants
- K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007 · cites it directly4descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202 | Spacelabs, Inc. | 1986 | — |
| −1 | K031479 | Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model… | Datex-Ohmeda, Inc. | 2003 | — |
| 0 (this device) | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring System | Healthstats International Pte., Ltd. | 2006 | — |
| +1 | K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte., Ltd. | 2018 | — |
| +2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +3 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +1 | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
| +4 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemSummary page 1…oduct Code: 74 DXN, 21 CFR § 870.1130 Class: Class II (3) Predicate Device(s): K900247 CBM-3000/CBM-2000/CBM-7000 Blood Pressure System, Colin Medical Instruments Corp. K… | 1990 |
| * | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202Summary page 1…redicate Device(s): K900247 CBM-3000/CBM-2000/CBM-7000 Blood Pressure System, Colin Medical Instruments Corp. K855127 Ambulatory Blood Pressure Monitor #90202, Spacelabs, Inc. K031479 Ambulatory Blood Pressure (ABP) 92506… | 1986 |
| * | K031479 | Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506Summary page 1…sure System, Colin Medical Instruments Corp. K855127 Ambulatory Blood Pressure Monitor #90202, Spacelabs, Inc. K031479 Ambulatory Blood Pressure (ABP) 92506 Report Management System, (Spacelabs) Datex-Ohmeda, Inc… | 2003 |
What descends from it? (19)
See all 194 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | 2018 | 13 |
| K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | 2007 | 4 |
| K101002 | A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 | 2010 | 2 |
| K131916 | Bprosoft Casp PC Software | 2014 | 0 |
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 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K173028 (Healthstats International Pte., Ltd., 2018) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K900247.
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.
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 blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro wrist-mounted tonometric monitor, a BPCalibrator MC3000 oscillometric blood pressure monitor for calibration, and BProSoft software, a PC-based computer program. Before each measurement session, the wrist device is calibrated using the oscillometric monitor. Once calibrated, the BPro…
Read the full statement (185 words)
The BPro® 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 wrist-mounted tonometric monitor, a BPCalibrator MC3000 oscillometric blood pressure monitor for calibration, and BProSoft 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 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 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/K060315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060315: Healthstats Bpro Ambulatory Blood Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060315
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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