510(k) · Cleared
ClearedMicrolife 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 Mar 12, 2019 as substantially equivalent to K172880 (Microlife Intellectual Property GmbH, 2018) after an 88-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Mar 12, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K903134 (1991). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 7 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 6 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 5 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 4 generations backK061471 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2006
- 3 generations backK111652 Microlife Automatic Talking Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011
- 2 generations backK131346 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2013
- 1 generation backK172880 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2018
- This deviceK183469 Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019
- Descendant · cites it directly · 0 of its ownK190818 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019
Most influential descendants
Showing 1 of 1 · See all- K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −7 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −6 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −5 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −4 | K061471 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC | Microlife Intellectual Property GmbH | 2006 | — |
| −3 | K111652 | Microlife Automatic Talking Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2011 | — |
| −2 | K131346 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2013 | — |
| −1 | K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2018 | — |
| 0 (this device) | K183469 | Microlife Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2019 | — |
| +1 | K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K172880 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorSummary page 4…3. Information for the 510(k) Cleared Device (Predicate Device): Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model P3GX1-5X (BP A3 PC), K172880, Microlife Intellectual Property GmbH. 4. Device Description: Microlife Upper Arm Automatic Digital Blood Pressure Mon… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | 2019 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K190818 (Microlife Intellectual Property GmbH, 2019) has gone furthest, with 0 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. 2019, 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 BP3GX1-5X (BP A3 PC) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual of 12 years and older, with arm circumference sizes ranging from 22 -52 cm by using a non-invasive oscillometric technique in an inflatable cuff being wrapped around the upper arm. The device is also validated for all adult diabetic users. The device…
Read the full statement (167 words)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3GX1-5X (BP A3 PC) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual of 12 years and older, with arm circumference sizes ranging from 22 -52 cm by using a non-invasive oscillometric technique in an inflatable cuff being wrapped around the upper arm.
The device is also validated for all adult diabetic users.
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 PC.
The blood pressure monitor is a fully automatic digital blood pressure measuring device for use by adults(also applicable to the diabetic patients) on the upper arm at home or in your doctor’s/nurse’s office.
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/K183469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183469: Microlife Digital Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183469
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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