510(k) · Cleared
ClearedWrist Blood Pressure Monitor Model BP4350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Nov 8, 2018 as substantially equivalent to K142917 (Omron Healthcare, Inc., 2014) after a 90-day review. Its family tree reaches back 3 generations to 2005. 10 later devices descend from it.
- Decided
- Nov 8, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042505 (2005). 4 ancestors in all, the oldest K003732 (2001). 10 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 2 generations backK123498 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2013
- 1 generation backK142917 BP652N (Hem-6300-Z)Omron Healthcare, Inc. · 2014
- This deviceK182166 Wrist Blood Pressure Monitor Model BP4350Omron Healthcare, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type…Joytech Healthcare Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK250548 Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B…Joytech Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK211288 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH · 2021
- Descendant · 3 generations on · 0 of its ownK261394 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186…JOYTECH Healthcare Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2022 · cites it directly5descendants
- K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd. · 2023 · 2 generations on2descendants
- K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd. · 2025 · 2 generations on1descendant
- K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property GmbH · 2021 · cites it directly1descendant
- K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −2 | K123498 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2013 | — |
| −1 | K142917 | BP652N (Hem-6300-Z) | Omron Healthcare, Inc. | 2014 | — |
| 0 (this device) | K182166 | Wrist Blood Pressure Monitor Model BP4350 | Omron Healthcare, Inc. | 2018 | — |
| +1 | K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2022 | — |
| +2 | K230566 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully… | Joytech Healthcare Co., Ltd. | 2023 | — |
| +2 | K250548 | Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) | Joytech Healthcare Co., Ltd. | 2025 | — |
| +1 | K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | 2021 | — |
| +3 | K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus… | JOYTECH Healthcare Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K142917 | BP652N (Hem-6300-Z)Summary page 5…a)(3)] The Wrist Blood Pressure Monitor Model BP4350 is substantially equivalent to the Omron BP652N (HEM-6300-Z) with APS Noninvasive Blood Pressure Measurement System (K142917). DEVICE DESCRIPTION [807.92(a)(4)] The Wrist Blood Pressure Monitor Model BP4350 (“BP4350”) is a battery-powered, automatic, no… | 2014 |
| † | K061822 | Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 | 2006 |
| † | K131742 | HEM-6131 | 2013 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K212115 (Joytech Healthcare Co., Ltd., 2022) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K142917.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 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?
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 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182166: Wrist Blood Pressure Monitor Model BP4350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182166
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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