510(k) · Cleared

Cleared

Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1

K001182510(k) TraditionalCleared Aug 1, 2000112-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 Aug 1, 2000 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.

Decided: Aug 1, 2000
Review: 112 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

38 later devices descend from it, 2 citing it directly.

This deviceK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
Descendant · cites it directly · 28 of its ownK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
Descendant · 2 generations on · 25 of its ownK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
Descendant · 3 generations on · 24 of its ownK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
Descendant · 4 generations on · 23 of its ownK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
Descendant · 5 generations on · 15 of its ownK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2002high 4 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 38 · See all

K012796Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002 · cites it directly28descendants
K051862PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic…Ya Horng Electronic Co., Ltd. · 2005 · 2 generations on25descendants
K072860YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood…Ya Horng Electronic Co., Ltd. · 2008 · 3 generations on24descendants
K090058YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…Ya Horng Electronic Co., Ltd. · 2009 · 4 generations on23descendants
K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionYa Horng Electronic Co., Ltd. · 2012 · 5 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001182	Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1	Microlife Corp.	2000	—
+1	K012796	Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000	Amluck, Inc.	2002	—
+2	K051862	PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R…	Ya Horng Electronic Co., Ltd.	2005	—
+3	K072860	YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital…	Ya Horng Electronic Co., Ltd.	2008	—
+4	K090058	YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U…	Ya Horng Electronic Co., Ltd.	2009	—
+5	K121025	YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth…	Ya Horng Electronic Co., Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	2	0
2007	1	0
2008	1	0
2009	3	0
2011	3	0
2012	4	0
2014	3	0
2015	2	0
2016	1	0
2017	2	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0
2022	3	0
2023	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K001182, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K012796	Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000	Amluck, Inc.	2002	28
K073398	Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)	Microlife Corp.	2007	9

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?

Of its descendants, K012796 (Amluck, Inc., 2002) has gone furthest, with 28 descendants of its own.

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	—

https://510kreport.com/device/K001182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001182: Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001182

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026