510(k) · Cleared

Cleared

YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB

K090058510(k) TraditionalCleared Apr 22, 2009104-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

Ya Horng Electronic Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 22, 2009 as substantially equivalent to K072860 (Ya Horng Electronic Co., Ltd., 2008) after a 104-day review. Its family tree reaches back 4 generations to 2000. 23 later devices descend from it.

Decided: Apr 22, 2009
Review: 104 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K001182 (2000). 23 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
3 generations backK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
2 generations backK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
1 generation backK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
This deviceK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
Descendant · cites it directly · 15 of its ownK121025 YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor…Ya Horng Electronic Co., Ltd. · 2012
Descendant · 2 generations on · 8 of its ownK140067 QardioarmQardio, Inc. · 2014
Descendant · 3 generations on · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015
Descendant · 2 generations on · 5 of its ownK161846 Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
Descendant · 4 generations on · 4 of its ownK171833 Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2011high 3 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 23 · See all

K121025YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth TransmissionYa Horng Electronic Co., Ltd. · 2012 · cites it directly15descendants
K140067QardioarmQardio, Inc. · 2014 · 2 generations on8descendants
K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · 3 generations on6descendants
K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016 · 2 generations on5descendants
K171833Digital Blood Pressure Monitor-Wrist StyleShenzhen Combei Technology Co., Ltd. · 2018 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001182	Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1	Microlife Corp.	2000	—
−3	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	—
−1	K072860	YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital…	Ya Horng Electronic Co., Ltd.	2008	—
0 (this device)	K090058	YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U…	Ya Horng Electronic Co., Ltd.	2009	—
+1	K121025	YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth…	Ya Horng Electronic Co., Ltd.	2012	—
+2	K140067	Qardioarm	Qardio, Inc.	2014	—
+3	K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	Fudakang Industrial Co., Ltd.	2015	—
+2	K161846	Automatic Arm Bluetooth Blood Pressure Monitor	Truly Instrument Limited	2016	—
+4	K171833	Digital Blood Pressure Monitor-Wrist Style	Shenzhen Combei Technology Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	3	0
2012	2	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0
2019	2	0
2020	1	0
2022	3	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K090058, 2000–2026Source: 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
*	K072860	YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood… Summary page 1 …sure (Predicate) Device : Monitor BP-]OOJ, BP-1J0J,; and Digital Wrist Blood Pressure Monitor BP-500, BP-510 510(k) No: K072860 El…	Ya Horng Electronic Co., Ltd.	2008	—
†	K051539	Tricot Blood Pressure Cuff	Ya Horng Electronic Co., Ltd.	2005	—

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K121025	YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission	Ya Horng Electronic Co., Ltd.	2012	15
K110872	Withings Blood Pressure Monitor	Withings	2011	3
K103046	Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type	Hosman International Co., Ltd.	2011	2

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 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K121025 (Ya Horng Electronic Co., Ltd., 2012) has gone furthest, with 15 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. 2009, this device’s year, is highlighted.

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 YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9.0" - 13.0" for Arm type.

Optional model: BP-700U, BP-700UB, and BP-700TUB, software in the PC for record archiving and printing purposes only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090058 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090058: YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090058

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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