510(k) · Cleared
ClearedElectronic Sphygmomanometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qingdao Yasee Medical Device Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 3, 2023 as substantially equivalent to K150908 (Sky Innovation Technology ( Shanghai) Limited, 2015) after a 207-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Mar 3, 2023
- Review
- 207 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042505 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK042505 Omron Digital Wrist Blood Pressure Monitor, Model Hem-609NOmron Healthcare, Inc. · 2005
- 3 generations backK122482 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- 2 generations backK123669 Transtek Wrist Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd. · 2012
- 1 generation backK150908 XM-01 Electronic Automatic Blood Pressure MonitorSky Innovation Technology ( Shanghai) Limited · 2015
- This deviceK222394 Electronic SphygmomanometersQingdao Yasee Medical Device Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042505 | Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N | Omron Healthcare, Inc. | 2005 | — |
| −3 | K122482 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| −2 | K123669 | Transtek Wrist Blood Pressure Monitor | Zhongshan Transtek Electronics Co., Ltd. | 2012 | — |
| −1 | K150908 | XM-01 Electronic Automatic Blood Pressure Monitor | Sky Innovation Technology ( Shanghai) Limited | 2015 | — |
| 0 (this device) | K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K150908 | XM-01 Electronic Automatic Blood Pressure MonitorSummary page 4…ulation Number 21 CFR 870.1130 Panel Cardiovascular General Product Code DXN Predicate Device Information: (1) K150908, “XM-01 Automatic Electronic Blood Pressure Monitor”, manufactured by “Sky Innovation Technology (Shanghai) Limited.”… | 2015 |
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 18 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 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. 2023, 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?
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222394: Electronic Sphygmomanometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222394
Report an extraction error
Are you the manufacturer?
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