510(k) · Cleared

Cleared

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D

K080337510(k) TraditionalCleared May 13, 200895-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microlife Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on May 13, 2008 as substantially equivalent to K013485 (Microlife Corp., 2002) and 1 other predicate after a 95-day review. Its family tree reaches back 3 generations to 1991. 12 later devices descend from it.

Decided: May 13, 2008
Review: 95 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K903134 (1991). 10 ancestors in all. 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
2 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
1 generation backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
This deviceK080337 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Corp. · 2008
Descendant · cites it directly · 6 of its ownK101275 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch…Microlife Intellectual Property GmbH · 2010
Descendant · 2 generations on · 4 of its ownK143341 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2015
Descendant · 3 generations on · 3 of its ownK152770 ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH · 2015 · Recalled
Descendant · cites it directly · 3 of its ownK112845 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011
Descendant · 4 generations on · 2 of its ownK200297 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all

K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH · 2010 · cites it directly6descendants
K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2015 · 2 generations on4descendants
K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH · 2015 · 3 generations on3descendants
K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011 · cites it directly3descendants
K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2020 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K903134	Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C	Omron Marshall Products, Inc.	1991	—
−2	K970211	Microlife Automatic Blood Pressure Monitor	Micro Weiss Electronics	1998	—
−1	K013485	Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with…	Microlife Corp.	2002	—
0 (this device)	K080337	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D	Microlife Corp.	2008	—
+1	K101275	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office…	Microlife Intellectual Property GmbH	2010	—
+2	K143341	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2015	—
+3	K152770	ProBP 2400 Digital Blood Pressure Device	Microlife Intellectual Property GmbH	2015	1
+1	K112845	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2011	—
+4	K200297	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1997	1	0
1999	1	0
2001	2	0
2002	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	1	0
2015	2	0
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K080337, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K013485	Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional… Summary page 1 …BP3MQ1-2D 3. Information for the 510(k) Cleared Device (Predicate Device): a. Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP3BTO-1, K#013485, Microlife Corporation. b. AfibAlbertTM , K#052767, Lechnologies Research, Inc. 4. Device Description: Microlife…	Microlife Corp.	2002	—
*	K052767	Afibalert Atrial Fibrillation Detector Summary page 1 …e (Predicate Device): a. Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP3BTO-1, K#013485, Microlife Corporation. b. AfibAlbertTM , K#052767, Lechnologies Research, Inc. 4. Device Description: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…	Lechnologies Research, Inc.	2006	—

Also cleared against K013485: 2 other devices →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101275	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…	Microlife Intellectual Property GmbH	2010	6
K112845	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2011	3
K100763	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch BP Home N…	Microlife Intellectual Property GmbH	2010	1

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 17 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
None of the 10 ancestors has a recall.
Of its descendants, K101275 (Microlife Intellectual Property GmbH, 2010) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K013485.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)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 BP3MQ1-2D is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.

The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080337 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080337: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080337

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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