510(k) Report

510(k) · Cleared

Cleared

Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N

K042505510(k) TraditionalCleared Apr 5, 2005202-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 Apr 5, 2005 after a 202-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 49 later devices descend from it.

Decided
Apr 5, 2005
Review
202 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

49 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2012: 5 descendants cleared2013: 3 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2016: 3 descendants cleared2015: 2 descendants cleared2014: 3 descendants cleared2022: 3 descendants cleared2018: 4 descendants cleared2023: 6 descendants cleared2020: 2 descendants cleared2019: 2 descendants cleared2017: 1 descendant cleared2021: 2 descendants cleared2025: 4 descendants cleared2026: 7 descendants cleared20052010201520202025
  1. This deviceK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
  2. Descendant · cites it directly · 21 of its ownK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
  3. Descendant · 2 generations on · 19 of its ownK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
  4. Descendant · cites it directly · 15 of its ownK131742 HEM-6131Omron Healthcare, Inc. · 2013
  5. Descendant · 2 generations on · 11 of its ownK182127 Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc. · 2018
  6. Descendant · 3 generations on · 10 of its ownK182166 Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc. · 2018

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12012: 52013: 32014: 32015: 22016: 32017: 12018: 42019: 22020: 22021: 22022: 32023: 62025: 42026: 7
2008high 7 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 49 · See all
  • K123498BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013 · cites it directly21descendants
  • K142917BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014 · 2 generations on19descendants
  • K131742HEM-6131Omron Healthcare, Inc. · 2013 · cites it directly15descendants
  • K182127Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc. · 2018 · 2 generations on11descendants
  • K182166Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc. · 2018 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042505Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc.2005—
+1K123498BP652N (Hem-6300-Z)Omron Healthcare, Inc.2013—
+2K142917BP652N (Hem-6300-Z)Omron Healthcare, Inc.2014—
+1K131742HEM-6131Omron Healthcare, Inc.2013—
+2K182127Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc.2018—
+3K182166Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201250
201330
201430
201520
201630
201710
201840
201920
202020
202120
202230
202360
202540
202670
FIG. 1 — Lineage of K042505, 2005–2026Source: 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), 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. #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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K123498BP652N (Hem-6300-Z)Omron Healthcare, Inc.201321
K131742HEM-6131Omron Healthcare, Inc.201315
K122482Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd.20125
K083043King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd.20085
K120430Microlife Wrist Watch Blood Preeure Monitor, BP3MO1-3PMicrolife Intellectual Property GmbH20124
K092163Full Automatic (Nibp) Blood Pressure Monitor, Model HL168KBHealth & Life Co., Ltd.20091
K131749HEM-6221Omron Healthcare, Inc.20130

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, K123498 (Omron Healthcare, Inc., 2013) has gone furthest, with 21 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—

What is it indicated for?

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Indications for use as stated in the FDA 510(k) statement.

More from Omron Healthcare, Inc.

68 FDA decisions under this applicant name. See the company

  • DEN230076Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ))…Omron Healthcare, Inc. · 2024
  • K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2021
  • K183215Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019
  • K190693HEM-6410T-ZL Wrist Blood Pressure MonitorOmron Healthcare, Inc. · 2019
  • K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc. · 2019

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/K042505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042505

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026