510(k) · Cleared
ClearedWrist Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuhai Yueja Medical Device Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 11, 2023 as substantially equivalent to K223291 (Shenzhen Pango Medical Electronics Co., Ltd., 2023) after an 89-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Dec 11, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001671 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK001671 Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model…Omron Healthcare, Inc. · 2000
- 6 generations backK030359 KD-726 Memory Wrist Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 5 generations backK070826 KD-795 Wrist Measurement Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 4 generations backK102920 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2010
- 3 generations backK131569 PG-800A SeriesShenzhen Pango Electronic Co., Ltd. · 2013
- 2 generations backK161845 Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. · 2017
- 1 generation backK223291 Electronic Blood Pressure MonitorShenzhen Pango Medical Electronics Co., Ltd. · 2023
- This deviceK232815 Wrist Blood Pressure MonitorZhuhai Yueja Medical Device Technology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001671 | Ultra Compact Wrist Blood Pressure Monitor with Intellisense, Model Hem-630 | Omron Healthcare, Inc. | 2000 | — |
| −6 | K030359 | KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −5 | K070826 | KD-795 Wrist Measurement Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −4 | K102920 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2010 | — |
| −3 | K131569 | PG-800A Series | Shenzhen Pango Electronic Co., Ltd. | 2013 | — |
| −2 | K161845 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2017 | — |
| −1 | K223291 | Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. | 2023 | — |
| 0 (this device) | K232815 | Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology 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 |
|---|---|---|---|
| * | K223291 | Electronic Blood Pressure MonitorSummary page 5…mber: Electronic Blood Pressure Monitor Regulatory Class II Review Panel Cardiovascular III Predicate Devices 510k Number K223291 Trade Name of Device: Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Ele… | 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 23 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 7 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?
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure. diastolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232815: Wrist Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232815
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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