510(k) · Cleared
ClearedMicrolife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U
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 Jun 14, 2006 as substantially equivalent to K040002 (Microlife Intellectual Property Gmb, 2004) after a 26-day review. Its family tree reaches back 2 generations to 2002. 20 later devices descend from it.
- Decided
- Jun 14, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021305 (2002). 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK021305 Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional…Microlife Corp. · 2002
- 1 generation backK040002 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1Microlife Intellectual Property Gmb · 2004
- This deviceK061403 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4UMicrolife Intellectual Property GmbH · 2006
- Descendant · cites it directly · 19 of its ownK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- Descendant · 2 generations on · 14 of its ownK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
- Descendant · 3 generations on · 12 of its ownK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
- Descendant · 4 generations on · 9 of its ownK131121 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- Descendant · 3 generations on · 9 of its ownK113238 Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K080177Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008 · cites it directly19descendants
- K092161Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009 · 2 generations on14descendants
- K093831Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010 · 3 generations on12descendants
- K131121Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · 4 generations on9descendants
- K113238Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd. · 2012 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021305 | Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal… | Microlife Corp. | 2002 | — |
| −1 | K040002 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 | Microlife Intellectual Property Gmb | 2004 | — |
| 0 (this device) | K061403 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U | Microlife Intellectual Property GmbH | 2006 | — |
| +1 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| +2 | K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | Health & Life Co., Ltd. | 2009 | — |
| +3 | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT | Health & Life Co., Ltd. | 2010 | — |
| +4 | K131121 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| +3 | K113238 | Full Automatic (Nibp) Blood Pressue Monitor | Health & Life Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K040002 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1Summary page 1…essure Monitor, Model BP3AX1-4U 3. Information for the 510(k) Cleared Device (Predicate Device): Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1, K#040002. 4. Device Description: The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 -4U is designed to measure… | 2004 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | 2008 | 19 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080177 (Nihon Seimitsu Sokki Co., Ltd., 2008) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K040002.
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 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U with semiconductor pressure sensor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the wrist.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061403: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061403
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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