510(k) Report

510(k) · Cleared

Cleared

Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C

K903134510(k) TraditionalCleared Jan 8, 1991175-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 8, 1991 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 125 later devices descend from it.

Decided
Jan 8, 1991
Review
175 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 4 descendants cleared1998: 1 descendant cleared2002: 1 descendant cleared2008: 7 descendants cleared2004: 1 descendant cleared2010: 6 descendants cleared2009: 5 descendants cleared2006: 2 descendants cleared2007: 3 descendants cleared2011: 6 descendants cleared2013: 4 descendants cleared2014: 2 descendants cleared2015: 5 descendants cleared2012: 4 descendants cleared2016: 3 descendants cleared2018: 5 descendants cleared2021: 11 descendants cleared2020: 4 descendants cleared2019: 6 descendants cleared2023: 14 descendants cleared2026: 10 descendants cleared2022: 6 descendants cleared2025: 7 descendants cleared2024: 8 descendants cleared1990200020102020
  1. This deviceK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
  2. Descendant · cites it directly · 123 of its ownK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
  3. Descendant · 2 generations on · 122 of its ownK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
  4. Descendant · 3 generations on · 120 of its ownK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
  5. Descendant · 4 generations on · 86 of its ownK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
  6. Descendant · 5 generations on · 46 of its ownK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12004: 12006: 22007: 32008: 72009: 52010: 62011: 62012: 42013: 42014: 22015: 52016: 32017: 42018: 52019: 62020: 42021: 112022: 62023: 142024: 82025: 72026: 10
1998high 14 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 125 · See all
  • K970211Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998 · cites it directly123descendants
  • K013485Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional…Microlife Corp. · 2002 · 2 generations on122descendants
  • K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004 · 3 generations on120descendants
  • K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006 · 4 generations on86descendants
  • K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…Ya Horng Electronic Co., Ltd. · 2008 · 5 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903134Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc.1991—
+1K970211Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics1998—
+2K013485Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with…Microlife Corp.2002—
+3K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp.2004—
+4K060686Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH2006—
+5K081590YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R…Ya Horng Electronic Co., Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200410
200620
200730
200870
200950
201060
201160
201240
201340
201420
201550
201630
201740
201850
201960
202040
2021110
202260
2023140
202480
202570
2026100
FIG. 1 — Lineage of K903134, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (125)

See all 125

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

NumberDeviceApplicantDecidedDescendants
K970211Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics1998123
K153600Consult Station TSH4D Sas20170

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, K970211 (Micro Weiss Electronics, 1998) has gone furthest, with 123 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

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
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

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

More from Omron Marshall Products, Inc.

3 FDA decisions under this applicant name. See the company

  • K903133Omron Oscillometric Digital BP Monitor-Hem-405COmron Marshall Products, Inc. · 1991
  • K901963Omron Travel Toothbrush, Model HT-B02Omron Marshall Products, Inc. · 1990

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K903134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903134: Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903134

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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