510(k) · Cleared

Cleared

Omron Oscillometric Digital BP Monitor-Hem-405C

K903133510(k) TraditionalCleared Jan 18, 1991185-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 Marshall Products, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jan 18, 1991 after a 185-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Jan 18, 1991
Review: 185 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

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

This deviceK903133 Omron Oscillometric Digital BP Monitor-Hem-405COmron Marshall Products, Inc. · 1991
Descendant · cites it directly · 1 of its ownK970139 Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIOMicro Weiss Electronics · 1998
Descendant · cites it directly · 0 of its ownK110501 HEM-4030Omron Healthcare, Inc. · 2011
Descendant · 2 generations on · 0 of its ownK073397 Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H…Microlife Corp. · 2007

Most influential descendants

Showing 3 of 3 · See all

K970139Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIOMicro Weiss Electronics · 1998 · cites it directly1descendant
K110501HEM-4030Omron Healthcare, Inc. · 2011 · cites it directly0descendants
K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K903133	Omron Oscillometric Digital BP Monitor-Hem-405C	Omron Marshall Products, Inc.	1991	—
+1	K970139	Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO	Micro Weiss Electronics	1998	—
+1	K110501	HEM-4030	Omron Healthcare, Inc.	2011	—
+2	K073397	Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)	Microlife Corp.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2007	1	0
2011	1	0

FIG. 1 — Lineage of K903133, 1991–2011Source: 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K970139	Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO	Micro Weiss Electronics	1998	1
K110501	HEM-4030	Omron Healthcare, Inc.	2011	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, K970139 (Micro Weiss Electronics, 1998) has gone furthest, with 1 descendant 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/K903133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903133: Omron Oscillometric Digital BP Monitor-Hem-405C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903133

Report an extraction error

Are you the manufacturer?

Record history

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