510(k) · Cleared
ClearedMicrolife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 20, 2007 as substantially equivalent to K001182 (Microlife Corp., 2000) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1991. 9 later devices descend from it.
- Decided
- Dec 20, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903134 (1991). 6 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 3 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 2 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 1 generation backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- This deviceK073398 Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 2007
- Descendant · cites it directly · 4 of its ownK120430 Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH · 2012
- Descendant · 2 generations on · 2 of its ownK151330 Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015
- Descendant · cites it directly · 2 of its ownK091415 Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK211288 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH · 2021
- Descendant · cites it directly · 1 of its ownK092456 Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3CMicrolife Intellectual Property GmbH · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120430Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH · 2012 · cites it directly4descendants
- K151330Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland · 2015 · 2 generations on2descendants
- K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200…Truly Instrument Co., Ltd. · 2009 · cites it directly2descendants
- K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH · 2021 · 3 generations on1descendant
- K092456Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3CMicrolife Intellectual Property GmbH · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −3 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −2 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −1 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| 0 (this device) | K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100) | Microlife Corp. | 2007 | — |
| +1 | K120430 | Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3P | Microlife Intellectual Property GmbH | 2012 | — |
| +2 | K151330 | Microlife Wrist Watch Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | 2015 | — |
| +1 | K091415 | Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200… | Truly Instrument Co., Ltd. | 2009 | — |
| +3 | K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | 2021 | — |
| +1 | K092456 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C | Microlife Intellectual Property GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 | 2000 |
| * | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APSummary page 1…Pressure Monitor, Model BP3BU1, K#001 182. PIs refer to Exhibit#2 for 510(K) summary of BP3BU1 Microlife Upper Arm Blood Pressure Monitor, Model BP3BTO-AP, K#041411.Pls refer to Exhibit#3 for 510(K) summary of BP3BTO-AP. 4. Device Description: Microlife WristWatch Blood Press… | 2004 |
What descends from it? (9)
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 16 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K120430 (Microlife Intellectual Property GmbH, 2012) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K001182.
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. 2007, 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 Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073398: Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073398
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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