510(k) · Cleared

Cleared

Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400

K042014510(k) SpecialCleared Aug 6, 200410-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

Sein Electronics Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Aug 6, 2004 as substantially equivalent to K032927 (Sein Electronics Co., Ltd., 2004) after a 10-day review. Its family tree reaches back 2 generations to 2000.

Decided: Aug 6, 2004
Review: 10 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003282 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003282 Full Auto Blood Pressure Monitor, Model SE-7700HSein Electronics Co., Ltd. · 2000
1 generation backK032927 Full Auto Arm Digital Blood Pressure MonitorSein Electronics Co., Ltd. · 2004
This deviceK042014 Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400Sein Electronics Co., Ltd. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003282	Full Auto Blood Pressure Monitor, Model SE-7700H	Sein Electronics Co., Ltd.	2000	—
−1	K032927	Full Auto Arm Digital Blood Pressure Monitor	Sein Electronics Co., Ltd.	2004	—
0 (this device)	K042014	Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400	Sein Electronics Co., Ltd.	2004	—

FIG. 1 — Lineage of K042014, 2000–2004Source: 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
*	K032927	Full Auto Arm Digital Blood Pressure Monitor Summary page 1 …14- Device Classification Name: Non Invasive blood pressure measuring system 15- Substantial Equivalency is claimed against the following device: 510K #K032927 Full Auto Arm Digital Blood Pressure Monitor, Model SE- 7070, manufactured by Sein Electronics Co., Ltd. 16- Descripti…	Sein Electronics Co., Ltd.	2004	—

What descends from it?

No later submission names this one as a predicate yet.

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 4 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
None of the 2 ancestors has a recall.

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?

This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042014 · printed Nov 3, 2026

Cite this page

510(k) Report. “K042014: Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042014

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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