510(k) · Cleared

Cleared

Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1

K040002510(k) TraditionalCleared Mar 22, 200480-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 Intellectual Property Gmb · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Mar 22, 2004 as substantially equivalent to K021305 (Microlife Corp., 2002) after an 80-day review. Its family tree reaches back 1 generation to 2002. 28 later devices descend from it.

Decided: Mar 22, 2004
Review: 80 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K021305 (2002). 28 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK021305 Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional…Microlife Corp. · 2002
This deviceK040002 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1Microlife Intellectual Property Gmb · 2004
Descendant · cites it directly · 20 of its ownK061403 Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4UMicrolife Intellectual Property GmbH · 2006
Descendant · 2 generations on · 19 of its ownK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
Descendant · 3 generations on · 14 of its ownK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
Descendant · 4 generations on · 12 of its ownK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
Descendant · 5 generations on · 9 of its ownK131121 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2005high 4 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 28 · See all

K061403Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4UMicrolife Intellectual Property GmbH · 2006 · cites it directly20descendants
K080177Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008 · 2 generations on19descendants
K092161Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009 · 3 generations on14descendants
K093831Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010 · 4 generations on12descendants
K131121Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013 · 5 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021305	Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal…	Microlife Corp.	2002	—
0 (this device)	K040002	Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1	Microlife Intellectual Property Gmb	2004	—
+1	K061403	Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U	Microlife Intellectual Property GmbH	2006	—
+2	K080177	Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV	Nihon Seimitsu Sokki Co., Ltd.	2008	—
+3	K092161	Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF	Health & Life Co., Ltd.	2009	—
+4	K093831	Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT	Health & Life Co., Ltd.	2010	—
+5	K131121	Full Automatic (Nibp) Blood Pressure Monitor	Health & Life Co., Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2008	1	0
2009	3	0
2010	1	0
2012	4	0
2013	2	0
2014	2	0
2015	2	0
2016	3	0
2018	1	0
2019	1	0
2020	2	0
2021	2	0
2026	1	0

FIG. 1 — Lineage of K040002, 2002–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K021305	Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal Printer Summary page 1 …life Wrist Watch Automatic Blood Pressure Monitor, Models Monitor, Model substantially equivalent to the Microlife Automatic Blood Pressure BP-3BU1-5, K# 021305. 4. Device Description: The Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to measure the…	Microlife Corp.	2002	—

Also cleared against K021305: 1 other device →

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K061403	Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U	Microlife Intellectual Property GmbH	2006	20
K151330	Microlife Wrist Watch Blood Pressure Monitor	Microlife Intellectual Property GmbH, Switzerland	2015	2
K061558	Microlife Wrist Watch Blood Pressure Monitor, Model BP3BU1-4U	Microlife Intellectual Property GmbH	2006	2
K050413	Amplief Wrist Blood Pressure Monitor, Model M600	Amplife Corporation	2005	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?

Its one ancestor has no recall.
Of its descendants, K061403 (Microlife Intellectual Property GmbH, 2006) has gone furthest, with 20 descendants of its own.
1 other device also cites its predicate K021305.

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.

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 Wrist Watch Blood Pressure Monitor, Model BP3AX1 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040002 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040002: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040002

Report an extraction error

Are you the manufacturer?

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