510(k) · Cleared

Cleared

Fully Automatic Electronic Blood Pressure Monitor

K162230510(k) AbbreviatedCleared Nov 18, 2016102-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

Adon Health Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Nov 18, 2016 as substantially equivalent to K102906 (Andon Health Co, Ltd., 2010) after a 102-day review. Its family tree reaches back 1 generation to 2010. 6 later devices descend from it.

Decided: Nov 18, 2016
Review: 102 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K102906 (2010). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK102906 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2010
This deviceK162230 Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. · 2016
Descendant · cites it directly · 5 of its ownK183534 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2019
Descendant · 2 generations on · 4 of its ownK210770 Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021
Descendant · 3 generations on · 1 of its ownK234041 Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully…Andon Health Co, Ltd. · 2024
Descendant · 4 generations on · 0 of its ownK251113 iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth…Andon Health Co, Ltd. · 2025
Descendant · 3 generations on · 0 of its ownK222887 Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure…Famidoc Technology Company Limited · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019high 2 (2023) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all

K183534Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2019 · cites it directly5descendants
K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2021 · 2 generations on4descendants
K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…Andon Health Co, Ltd. · 2024 · 3 generations on1descendant
K251113iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless…Andon Health Co, Ltd. · 2025 · 4 generations on0descendants
K222887Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure MonitorFamidoc Technology Company Limited · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K102906	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co, Ltd.	2010	—
0 (this device)	K162230	Fully Automatic Electronic Blood Pressure Monitor	Adon Health Co., Ltd.	2016	—
+1	K183534	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co, Ltd.	2019	—
+2	K210770	Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor	Andon Health Co, Ltd.	2021	—
+3	K234041	Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic…	Andon Health Co, Ltd.	2024	—
+4	K251113	iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro…	Andon Health Co, Ltd.	2025	—
+3	K222887	Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor	Famidoc Technology Company Limited	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2021	1	0
2023	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K162230, 2010–2025Source: 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
*	K102906	Fully Automatic Electronic Blood Pressure Monitor Summary page 4 …diovascular 4.0 Predicate device information Manufacturer: Andon Health Co., Ltd. Device: KD-5964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906 K162230 Page 1 of 3 KD-5920, 5920L an…	Andon Health Co, Ltd.	2010	—

Also cleared against K102906: 4 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K183534	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co, Ltd.	2019	5

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, K183534 (Andon Health Co, Ltd., 2019) has gone furthest, with 5 descendants of its own.
4 other devices also cite its predicate K102906.

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. 2016, 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?

KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162230 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162230: Fully Automatic Electronic Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162230

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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