510(k) · Cleared
ClearedWrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Urion Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 14, 2026 as substantially equivalent to K231367 (Shenzhen Finicare Co., Ltd., 2023) after a 148-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- May 14, 2026
- Review
- 148 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042505 (2005). No later device cites it as a predicate yet.
- Root · 5 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 4 generations backK083043 King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd. · 2008
- 3 generations backK112042 Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 2012
- 2 generations backK182018 Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2018
- 1 generation backK231367 Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201…Shenzhen Finicare Co., Ltd. · 2023
- This deviceK254048 Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P…Shenzhen Urion Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −4 | K083043 | King`Yield Wrist Blood Pressure Monitor, Model BP201 | Shenzhen Kingyield Technology Co., Ltd. | 2008 | — |
| −3 | K112042 | Kingyield Wrist Blood Pressure Monitor | Shenzhen Kingyield Technology Co., Ltd. | 2012 | — |
| −2 | K182018 | Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd. | 2018 | — |
| −1 | K231367 | Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201… | Shenzhen Finicare Co., Ltd. | 2023 | — |
| 0 (this device) | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M… | Shenzhen Urion Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K231367 | Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211…Summary page 5…Product code: DXN Regulatory Class: Class Ⅱ 3. Predicate Wrist Electronic Blood Pressure Monitor Device(s): K231367/Shenzhen Finicare Co., Ltd. This device is a digital self-monitor intended for use in measuring blood 4.… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
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. 2026, 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 Wrist Watch Electronic Blood Pressure Monitor uses the oscillometric method to measure diastolic blood pressure, systolic blood pressure. It is intended for use in adults with a wrist circumference between 15-21 cm who do not have arrhythmias (such as atrial fibrillation) and who are not pregnant. The values are for reference purposes and do not constitute a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254048: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254048
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026