510(k) · Cleared

Cleared

Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312

K012054510(k) TraditionalCleared Aug 8, 200137-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 8, 2001 after a 37-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided: Aug 8, 2001
Review: 37 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

6 later devices descend from it, 3 citing it directly.

This deviceK012054 Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312Sein Electronics Co., Ltd. · 2001
Descendant · cites it directly · 3 of its ownK042138 Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311Sein Electronics Co., Ltd. · 2004
Descendant · 2 generations on · 2 of its ownK052108 Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005
Descendant · cites it directly · 0 of its ownK092061 Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217Genexel Medical Instrument, Inc. · 2010
Descendant · 3 generations on · 0 of its ownK080853 Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009
Descendant · 3 generations on · 0 of its ownK080636 Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all

K042138Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311Sein Electronics Co., Ltd. · 2004 · cites it directly3descendants
K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005 · 2 generations on2descendants
K092061Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217Genexel Medical Instrument, Inc. · 2010 · cites it directly0descendants
K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009 · 3 generations on0descendants
K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012054	Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312	Sein Electronics Co., Ltd.	2001	—
+1	K042138	Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311	Sein Electronics Co., Ltd.	2004	—
+2	K052108	Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100	Sein Electronics Co., Ltd.	2005	—
+1	K092061	Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217	Genexel Medical Instrument, Inc.	2010	—
+3	K080853	Duo-Care Blood Glucose and Blood Pressure Monitor System	Genexel-Sein, Inc.	2009	—
+3	K080636	Duo-Max Blood Pressure & Glucose Monitor HMF-100	Hubdic Co., Ltd.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	1	0
2009	2	0
2010	1	0

FIG. 1 — Lineage of K012054, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K042138	Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311	Sein Electronics Co., Ltd.	2004	3
K092061	Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217	Genexel Medical Instrument, Inc.	2010	0
K071523	Full Auto Wrist Digital Blood Pressure Monitor, Models BP1600, BP1650, BP1700 and BP1750	Genexel-Sein, Inc.	2007	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, K042138 (Sein Electronics Co., Ltd., 2004) has gone furthest, with 3 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	—

What is it indicated for?

To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012054: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012054

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026