510(k) · Cleared
ClearedMicrolife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Intellectual Property GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Feb 3, 2023 as substantially equivalent to K200297 (Microlife Intellectual Property GmbH, 2020) and 2 other predicates after a 198-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Feb 3, 2023
- Review
- 198 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K903134 (1991). 33 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 7 generations between
- 3 generations backK143341 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2015
- 2 generations backK152770 ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH · 2015 · Recalled
- 1 generation backK200297 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020
- This deviceK222153 Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office…Microlife Intellectual Property GmbH · 2023
Show all 11 generations
- Root · 11 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 10 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 9 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 8 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 7 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 6 generations backK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
- 5 generations backK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- 4 generations backK101275 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch…Microlife Intellectual Property GmbH · 2010
- 3 generations backK143341 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2015
- 2 generations backK152770 ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH · 2015 · Recalled
- 1 generation backK200297 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020
- This deviceK222153 Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office…Microlife Intellectual Property GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −10 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −9 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −8 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −7 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −6 | K073198 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −5 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −4 | K101275 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office… | Microlife Intellectual Property GmbH | 2010 | — |
| −3 | K143341 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2015 | — |
| −2 | K152770 | ProBP 2400 Digital Blood Pressure Device | Microlife Intellectual Property GmbH | 2015 | 1 |
| −1 | K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2020 | — |
| 0 (this device) | K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular… | Microlife Intellectual Property GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K200297 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorSummary page 5…Device (Predicate Device): Primary Predicate: a. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B), K200297, Microlife Intellectual Property GmbH. Reference Predicate: b. Microlife Upper Arm Automatic Digital Blo… | 2020 |
| * | K112845 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorSummary page 5…y GmbH. Reference Predicate: b. Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office ABI (TWIN200 ABI), K112845, Microlife Intellectual Property GmbH. c. BP-203RPE II Series VP-1000 monitor, K013434, Colin Corporation.… | 2011 |
| * | K013434 | VP-2000/1000Summary page 5…ssure Monitor, Model WatchBP Office ABI (TWIN200 ABI), K112845, Microlife Intellectual Property GmbH. c. BP-203RPE II Series VP-1000 monitor, K013434, Colin Corporation. 1… | 2002 |
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 32 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 33 ancestors has a recall of any class.
- 1 other device also cites its predicate K200297.
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. 2023, 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 Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14-52 cm…
Read the full statement (248 words)
The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14-52 cm (5.5-20.5 inches).
The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.
The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy.
The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD).
The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without any diagnosis.
The memory data can be transferred to the PC running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.
The device is intended for use by healthcare professionals in clinical practice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222153
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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