510(k) · Cleared

Cleared

Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC

K060686510(k) SpecialCleared Jun 9, 200686-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 GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jun 9, 2006 as substantially equivalent to K041411 (Microlife Corp., 2004) after an 86-day review. Its family tree reaches back 4 generations to 1991. 86 later devices descend from it.

Decided: Jun 9, 2006
Review: 86 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K903134 (1991). 5 ancestors in all. 86 later devices descend from it, 4 citing it directly.

By dateBy generation

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 deviceK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
Descendant · cites it directly · 46 of its ownK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
Descendant · 2 generations on · 45 of its ownK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
Descendant · cites it directly · 36 of its ownK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
Descendant · 3 generations on · 35 of its ownK101487 Cheetah Nicom SystemCheetah Medical, Inc. · 2010
Descendant · 4 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2008high 13 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 86 · See all

K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd. · 2008 · cites it directly46descendants
K083093Cheetah ReliantCheetah Medical, Inc. · 2008 · 2 generations on45descendants
K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…Microlife Intellectual Property GmbH · 2008 · cites it directly36descendants
K101487Cheetah Nicom SystemCheetah Medical, Inc. · 2010 · 3 generations on35descendants
K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 4 generations on34descendants

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)	K060686	Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC	Microlife Intellectual Property GmbH	2006	—
+1	K081590	YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R…	Ya Horng Electronic Co., Ltd.	2008	—
+2	K083093	Cheetah Reliant	Cheetah Medical, Inc.	2008	1
+1	K073198	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp…	Microlife Intellectual Property GmbH	2008	—
+3	K101487	Cheetah Nicom System	Cheetah Medical, Inc.	2010	—
+4	K190205	HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module	Edwards Lifesciences, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	6	0
2010	5	0
2011	5	0
2012	1	0
2013	2	0
2014	1	0
2015	3	0
2016	2	0
2017	2	0
2018	3	0
2019	3	0
2020	4	0
2021	9	0
2022	5	0
2023	13	0
2024	7	0
2025	6	0
2026	9	0

FIG. 1 — Lineage of K060686, 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

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
*	K041411	Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP	Microlife Corp.	2004	—

Also cleared against K041411: 5 other devices →

What descends from it? (86)

See all 86

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

Number	Device	Applicant	Decided	Descendants
K081590	YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…	Ya Horng Electronic Co., Ltd.	2008	46
K073198	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…	Microlife Intellectual Property GmbH	2008	36
K122013	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)	Microlife Corp.	2013	0
K072752	BP Limbo XL, Bptango XL, BP Salsa XL	Datadancer Medical Systems	2008	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 15 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K081590 (Ya Horng Electronic Co., Ltd., 2008) has gone furthest, with 46 descendants of its own.
5 other devices also cite its predicate K041411.

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 Automatic Blood Pressure Monitor, Model BP 3AC1-1 PC is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the upper arm.

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/K060686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060686: Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060686

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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