510(k) · Cleared
ClearedKing`Yield Wrist Blood Pressure Monitor, Model BP201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kingyield Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 27, 2008 as substantially equivalent to K042505 (Omron Healthcare, Inc., 2005) after a 13-day review. Its family tree reaches back 1 generation to 2005. 5 later devices descend from it.
- Decided
- Oct 27, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042505 (2005). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- This deviceK083043 King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK112042 Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK182018 Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK231367 Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201…Shenzhen Finicare Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK254048 Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P…Shenzhen Urion Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK152415 Digital Blood Pressure MonitorSuzhou Sunspirit Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K112042Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 2012 · cites it directly3descendants
- K182018Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2018 · 2 generations on2descendants
- K231367Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211…Shenzhen Finicare Co., Ltd. · 2023 · 3 generations on1descendant
- K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S…Shenzhen Urion Technology Co., Ltd. · 2026 · 4 generations on0descendants
- K152415Digital Blood Pressure MonitorSuzhou Sunspirit Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| 0 (this device) | K083043 | King`Yield Wrist Blood Pressure Monitor, Model BP201 | Shenzhen Kingyield Technology Co., Ltd. | 2008 | — |
| +1 | K112042 | Kingyield Wrist Blood Pressure Monitor | Shenzhen Kingyield Technology Co., Ltd. | 2012 | — |
| +2 | K182018 | Bluetooth blood pressure monitor | Shenzhen Kingyield Technology Co., Ltd. | 2018 | — |
| +3 | K231367 | Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201… | Shenzhen Finicare Co., Ltd. | 2023 | — |
| +4 | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M… | Shenzhen Urion Technology Co., Ltd. | 2026 | — |
| +1 | K152415 | Digital Blood Pressure Monitor | Suzhou Sunspirit Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NSummary page 2…t Code: DXN 5. Classification Panel: Cardiovascular 6. Predicate Device: 1-WM-609N Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC. K 042505 (Predicate) 7. Device Description: BP20 1 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monito… | 2005 |
What descends from it? (5)
2 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?
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. 2008, 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?
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083043 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083043: King`Yield Wrist Blood Pressure Monitor, Model BP201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083043
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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