510(k) · Cleared

Cleared

Microlife Automatic Blood Pressure Monitor

K970211510(k) TraditionalCleared Apr 30, 1998464-day reviewClass II21 CFR 870.2100

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

Micro Weiss Electronics · DPW Flowmeter, Blood, Cardiovascular

Cleared on Apr 30, 1998 as substantially equivalent to K903134 (Omron Marshall Products, Inc., 1991) after a 464-day review. Its family tree reaches back 1 generation to 1991. 123 later devices descend from it.

Decided: Apr 30, 1998
Review: 464 days
Class: Class II
Product code: DPW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903134 (1991). 123 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
This deviceK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
Descendant · cites it directly · 122 of its ownK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
Descendant · 2 generations on · 120 of its ownK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
Descendant · 3 generations on · 86 of its ownK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
Descendant · 4 generations on · 46 of its ownK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
Descendant · 5 generations on · 45 of its ownK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

2002high 14 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 123 · See all

K013485Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional…Microlife Corp. · 2002 · cites it directly122descendants
K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004 · 2 generations on120descendants
K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006 · 3 generations on86descendants
K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd. · 2008 · 4 generations on46descendants
K083093Cheetah ReliantCheetah Medical, Inc. · 2008 · 5 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903134	Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C	Omron Marshall Products, Inc.	1991	—
0 (this device)	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	—
+2	K041411	Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP	Microlife Corp.	2004	—
+3	K060686	Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC	Microlife Intellectual Property GmbH	2006	—
+4	K081590	YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R…	Ya Horng Electronic Co., Ltd.	2008	—
+5	K083093	Cheetah Reliant	Cheetah Medical, Inc.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
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 K970211, 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 DPW? 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 DPW device

#1 K251114 FloPatch FP120score 13.8 · 5 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
*	K903134	Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C Summary page 1 …ife Automatic Blood Pressure Monitor, Model BP-2BHO is substantially equivalent to the Qmron Auto-Inflate Oscillometric Digital Blood Pressure Monitor, Model HEM-705C, K#903134. 4, Device Description: The BP-2BHO Digital Blood Pressure Monitor is designed to measure the systolic, diastalic and pulse rai…	Omron Marshall Products, Inc.	1991	—

Also cleared against K903134: 1 other device →

What descends from it? (123)

See all 123

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013485	Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional…	Microlife Corp.	2002	122

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, K013485 (Microlife Corp., 2002) has gone furthest, with 122 descendants of its own.
1 other device also cites its predicate K903134.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPW

3in 2025

2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2007high 275 (2015) · low 89 (2011)2026

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

Recalls per year · DPW

1in 2025

2007high 4 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DPW

6in 2025

2007high 12 (2015) · low 0 (2007)2025

MAUDE reports naming product code DPW, 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	1	—	4	0
2008	1	—	0	0
2009	0	—	0	1
2010	2	—	1	0
2011	4	89	0	1
2012	1	—	1	0
2013	2	—	0	3
2014	0	—	0	8
2015	3	275	0	12
2016	1	—	0	1
2017	0	—	1	2
2018	2	—	0	0
2019	3	169	0	3
2020	2	—	0	4
2021	2	—	0	6
2022	3	136	0	1
2023	1	—	0	2
2024	1	—	0	4
2025	3	119	1	6
2026	2	—	0	—

What is it indicated for?

The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

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/K970211 · printed Nov 3, 2026

Cite this page

510(k) Report. “K970211: Microlife Automatic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970211

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