510(k) · Cleared

Cleared

KD-622 Fully Automatic Electronic Blood Pressure Monitor

K030358510(k) TraditionalCleared Oct 31, 2003270-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

Kodon (Tianjin)Electronic&Electrical Apparatus Co., · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Oct 31, 2003 as substantially equivalent to K001670 (Omron Healthcare, Inc., 2000) after a 270-day review. Its family tree reaches back 1 generation to 2000. 99 later devices descend from it.

Decided: Oct 31, 2003
Review: 270 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001670 (2000). 99 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
This deviceK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
Descendant · cites it directly · 95 of its ownK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
Descendant · 2 generations on · 51 of its ownK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
Descendant · 3 generations on · 46 of its ownK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
Descendant · 4 generations on · 34 of its ownK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
Descendant · 5 generations on · 33 of its ownK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2005high 17 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 99 · See all

K070828KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007 · cites it directly95descendants
K080319KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008 · 2 generations on51descendants
K090963Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009 · 3 generations on46descendants
K101950Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010 · 4 generations on34descendants
K102939Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011 · 5 generations on33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001670	Automatic Blood Pressure Monitor with Intellisense, Model Hem-757	Omron Healthcare, Inc.	2000	—
0 (this device)	K030358	KD-622 Fully Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2003	—
+1	K070828	KD-595 Fully Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2007	—
+2	K080319	KD-591 Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co, Ltd.	2008	—
+3	K090963	Fully Automatic Electronic Blood Pressure Monitor, Model KD-556	Andon Health Co, Ltd.	2009	—
+4	K101950	Fully Automatic Electronic Blood Pressure Monitor Model KD-930	Andon Health Co, Ltd.	2010	—
+5	K102939	Fully Automatic Electronic Blood Pressure Monitor Model KD-931	Andon Health Co, Ltd.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2008	2	0
2009	17	0
2010	10	0
2011	6	0
2012	3	0
2013	4	0
2014	3	0
2015	4	0
2016	4	0
2017	5	0
2018	3	0
2019	4	0
2020	3	0
2021	4	0
2022	6	0
2023	6	0
2024	5	0
2025	5	0
2026	2	0

FIG. 1 — Lineage of K030358, 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
*	K001670	Automatic Blood Pressure Monitor with Intellisense, Model Hem-757	Omron Healthcare, Inc.	2000	—

Also cleared against K001670: 4 other devices →

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K070828	KD-595 Fully Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2007	95
K042418	KD-575 Memory Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2005	3
K070395	KD-525E Fully Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2007	2
K083395	Semi-Fully Automatic Electronic Blood Pressure Monitor, Models…	Andon Health Co, Ltd.	2009	1

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, K070828 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2007) has gone furthest, with 95 descendants of its own.
4 other devices also cite its predicate K001670.

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 KD-622 Fully 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 8.6614 inches to 13.78 inches.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030358 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030358: KD-622 Fully Automatic Electronic 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/K030358

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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