510(k) · Cleared

Cleared

Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630

K001671510(k) SpecialCleared Jun 30, 200029-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

Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jun 30, 2000 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 42 later devices descend from it.

Decided: Jun 30, 2000
Review: 29 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

42 later devices descend from it, 2 citing it directly.

This deviceK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
Descendant · cites it directly · 40 of its ownK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
Descendant · 2 generations on · 33 of its ownK070826 KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
Descendant · 3 generations on · 8 of its ownK090769 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009
Descendant · 4 generations on · 7 of its ownK091997 Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009
Descendant · 3 generations on · 6 of its ownK150430 Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2003high 11 (2009) · low 0 (2005)2026

Most influential descendants

Showing 5 of 42 · See all

K030359KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003 · cites it directly40descendants
K070826KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007 · 2 generations on33descendants
K090769Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961Andon Health Co, Ltd. · 2009 · 3 generations on8descendants
K091997Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962Andon Health Co, Ltd. · 2009 · 4 generations on7descendants
K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd. · 2015 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001671	Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630	Omron Healthcare, Inc.	2000	—
+1	K030359	KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2003	—
+2	K070826	KD-795 Wrist Measurement Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2007	—
+3	K090769	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961	Andon Health Co, Ltd.	2009	—
+4	K091997	Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962	Andon Health Co, Ltd.	2009	—
+3	K150430	Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor	Fudakang Industrial Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	2	0
2007	1	0
2008	1	0
2009	11	0
2010	5	0
2011	2	0
2013	2	0
2015	2	0
2016	1	0
2017	2	0
2018	3	0
2020	1	0
2021	1	0
2022	2	0
2023	3	0
2026	1	0

FIG. 1 — Lineage of K001671, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K030359	KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor	Kodon (Tianjin)Electronic&Electrical Apparatus Co.,	2003	40
K041789	Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900T	Meditec Co., Ltd.	2004	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?

Of its descendants, K030359 (Kodon (Tianjin)Electronic&Electrical Apparatus Co.,, 2003) has gone furthest, with 40 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	—

https://510kreport.com/device/K001671 · printed Nov 4, 2026

Cite this page

510(k) Report. “K001671: Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001671

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026