510(k) · Cleared
ClearedMicrolife Upper Arm Automatic Digital Blood Pressure Monitor
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 Dec 16, 2015 as substantially equivalent to K061471 (Microlife Intellectual Property GmbH, 2006) after a 16-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it.
- Decided
- Dec 16, 2015
- Review
- 16 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903134 (1991). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 4 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 3 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 2 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 1 generation backK061471 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2006
- This deviceK153450 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2015
- Descendant · cites it directly · 3 of its ownK172498 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2017
- Descendant · cites it directly · 2 of its ownK230075 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2023
- Descendant · 2 generations on · 1 of its ownK251120 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK253982 Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK170467 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2017
Most influential descendants
Showing 5 of 5 · See all- K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH · 2017 · cites it directly3descendants
- K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH · 2023 · cites it directly2descendants
- K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation · 2025 · 2 generations on1descendant
- K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −4 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −3 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −2 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −1 | K061471 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC | Microlife Intellectual Property GmbH | 2006 | — |
| 0 (this device) | K153450 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2015 | — |
| +1 | K172498 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y | Microlife Intellectual Property GmbH | 2017 | — |
| +1 | K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH | 2023 | — |
| +2 | K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP… | Microlife Corporation | 2025 | — |
| +3 | K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026 | — |
| +1 | K170467 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K061471 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PCSummary page 4…ode: DXN 3. Information for the 510(k) Cleared Device (Predicate Device): Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471, Microlife Intellectual Property GmbH. 4. Device Description: Microlife Upper Arm Automatic Digital Blood Pressure Mon… | 2006 |
| † | K131346 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | 2013 |
What descends from it? (5)
3 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172498 (Microlife Intellectual Property GmbH, 2017) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K061471.
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. 2015, 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 Monitor, Model BP3MS1-4A (BP A200 Comfort) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 14 -52 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm. The device detects the appearance of irregular heartbeat during measurement, and…
Read the full statement (121 words)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-4A (BP A200 Comfort) is a device
intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference
sizes ranging from 14 -52 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped
around the single upper arm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading
once the irregular heartbeat is detected.
The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer
(BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153450: Microlife Upper Arm Automatic Digital Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153450
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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