510(k) · Cleared

Cleared

Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PR 1KA1

K013485510(k) TraditionalCleared Jan 17, 200290-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 Jan 17, 2002 as substantially equivalent to K970211 (Micro Weiss Electronics, 1998) after a 90-day review. Its family tree reaches back 2 generations to 1991. 122 later devices descend from it.

Decided: Jan 17, 2002
Review: 90 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K903134 (1991). 122 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
1 generation backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
This deviceK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
Descendant · cites it directly · 120 of its ownK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
Descendant · 2 generations on · 86 of its ownK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
Descendant · 3 generations on · 46 of its ownK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
Descendant · 4 generations on · 45 of its ownK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
Descendant · 3 generations on · 36 of its ownK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008

Showing 5 of 122 descendants. See all descendants

Descendants cleared per year

2004high 14 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 122 · See all

K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004 · cites it directly120descendants
K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006 · 2 generations on86descendants
K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd. · 2008 · 3 generations on46descendants
K083093Cheetah ReliantCheetah Medical, Inc. · 2008 · 4 generations on45descendants
K073198Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home…Microlife Intellectual Property GmbH · 2008 · 3 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903134	Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C	Omron Marshall Products, Inc.	1991	—
−1	K970211	Microlife Automatic Blood Pressure Monitor	Micro Weiss Electronics	1998	—
0 (this device)	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	—
+2	K060686	Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC	Microlife Intellectual Property GmbH	2006	—
+3	K081590	YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R…	Ya Horng Electronic Co., Ltd.	2008	—
+4	K083093	Cheetah Reliant	Cheetah Medical, Inc.	2008	1
+3	K073198	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp…	Microlife Intellectual Property GmbH	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2007	3	0
2008	7	0
2009	5	0
2010	6	0
2011	6	0
2012	4	0
2013	4	0
2014	2	0
2015	5	0
2016	3	0
2017	3	0
2018	5	0
2019	6	0
2020	4	0
2021	11	0
2022	6	0
2023	14	0
2024	8	0
2025	7	0
2026	10	0

FIG. 1 — Lineage of K013485, 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? (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
*	K970211	Microlife Automatic Blood Pressure Monitor Summary page 1 …e Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 is substantially equivalent to the Microlife Automatic Blood Pressure Monitor, Model BP-2BHO, K# 970211. Device Description: The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 is designed to measure the systo…	Micro Weiss Electronics	1998	—

What descends from it? (122)

See all 122

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

Number	Device	Applicant	Decided	Descendants
K041411	Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP	Microlife Corp.	2004	120
K080337	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D	Microlife Corp.	2008	12
K101512	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…	Microlife Intellectual Property GmbH	2010	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 11 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K041411 (Microlife Corp., 2004) has gone furthest, with 120 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	—

What is it indicated for?

The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1

with Optional Thermal Printer, Model PR 1KA1 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 upper arm. This device can be used in connection with the Microlife Thermal

Printer.

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/K013485 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013485: Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PR 1KA1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013485

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026