510(k) · Cleared
ClearedBluetooth blood pressure monitor
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 6, 2018 as substantially equivalent to K112042 (Shenzhen Kingyield Technology Co., Ltd., 2012) after a 71-day review. Its family tree reaches back 3 generations to 2005. 2 later devices descend from it.
- Decided
- Oct 6, 2018
- Review
- 71 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042505 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 2 generations backK083043 King`Yield Wrist Blood Pressure Monitor, Model BP201Shenzhen Kingyield Technology Co., Ltd. · 2008
- 1 generation backK112042 Kingyield Wrist Blood Pressure MonitorShenzhen Kingyield Technology Co., Ltd. · 2012
- This deviceK182018 Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK231367 Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201…Shenzhen Finicare Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK254048 Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P…Shenzhen Urion Technology Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See all- K231367Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211…Shenzhen Finicare Co., Ltd. · 2023 · cites it directly1descendant
- K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S…Shenzhen Urion Technology Co., Ltd. · 2026 · 2 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 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M… | Shenzhen Urion Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112042 | Kingyield Wrist Blood Pressure MonitorSummary page 4…E/UNMODIFIED DEVICE Device Name: BP210 Wrist Blood Pressure Monitor Common/Usual Name: Wrist Blood Pressure Monitor BP210 510(k) Number: K112042 510(k) submitter/holder: Shenzhen Kingyield Technology Co., Ltd. IV. MODIFIED DEVICE DESCRIPTION Blueto… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231367 | Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211… | 2023 | 1 |
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 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231367 (Shenzhen Finicare Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
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?
This blood pressure monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182018: Bluetooth blood pressure monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182018
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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