510(k) · Cleared
ClearedCBM-3000/CBM-2000/CBM-7000 Blood Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colin Medical Instruments Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 17, 1990 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.
- Decided
- Jul 17, 1990
- Review
- 181 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 3 citing it directly.
- This deviceK900247 CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemColin Medical Instruments Corp. · 1990
- Descendant · cites it directly · 19 of its ownK060315 Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006
- Descendant · 2 generations on · 13 of its ownK173028 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT…Healthstats International Pte., Ltd. · 2018
- Descendant · 3 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 4 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 2 generations on · 4 of its ownK072593 A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006 · cites it directly19descendants
- K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareHealthstats International Pte., Ltd. · 2018 · 2 generations on13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 3 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 4 generations on5descendants
- K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd. · 2007 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure System | Colin Medical Instruments Corp. | 1990 | — |
| +1 | K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring System | Healthstats International Pte., Ltd. | 2006 | — |
| +2 | K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte., Ltd. | 2018 | — |
| +3 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +4 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +2 | K072593 | A-Plus Arterial Pulse Waveform Analysis System and PC Software | Healthstats International Pte., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 253 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?
- Of its descendants, K060315 (Healthstats International Pte., Ltd., 2006) has gone furthest, with 19 descendants of its own.
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 | — |
https://510kreport.com/device/K900247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900247: CBM-3000/CBM-2000/CBM-7000 Blood Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900247
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026