510(k) · Cleared
ClearedWrist Blood Pressure Monitor (XW-05)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Ziqing Medical Equipment Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 18, 2026 as substantially equivalent to K231310 (Shenzhen Jumper Medical Equipment Co., Ltd., 2023) after a 266-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jun 18, 2026
- Review
- 266 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 backK131742 HEM-6131Omron Healthcare, Inc. · 2013
- 2 generations backK182127 Wrist Blood Pressure Monitor Model BP6100Omron Healthcare, Inc. · 2018
- 1 generation backK231310 Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd. · 2023
- This deviceK253126 Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd. · 2026
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 | K131742 | HEM-6131 | Omron Healthcare, Inc. | 2013 | — |
| −2 | K182127 | Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. | 2018 | — |
| −1 | K231310 | Electronic Blood Pressure Monitor | Shenzhen Jumper Medical Equipment Co., Ltd. | 2023 | — |
| 0 (this device) | K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment 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 |
|---|---|---|---|
| * | K231310 | Electronic Blood Pressure MonitorSummary page 6…Page 1 of 7 510(k) Summary K253126 510(k) number: K231310 4.0 Indication for Use Statement This wrist blood pressure monitor is used to measure the systolic blood pressure, diastolic bl… | 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 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K231310.
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?
This wrist blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The blood pressure monitor uses the oscillometric measurement method to inflate the cuff and pressurize it, detect the blood flow in the wrist arteries, and then convert your blood pressure into a digital reading through this device. The device is simple and convenient to use, and the patient can complete the measurement by…
Read the full statement (116 words)
This wrist blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The blood pressure monitor uses the oscillometric measurement method to inflate the cuff and pressurize it, detect the blood flow in the wrist arteries, and then convert your blood pressure into a digital reading through this device. The device is simple and convenient to use, and the patient can complete the measurement by themselves. This device is suitable for non-invasive monitoring of blood pressure and pulse rate in adults (18 years and above), and is limited to auxiliary measurements in home and medical environments, and cannot be used as the sole basis for clinical diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253126: Wrist Blood Pressure Monitor (XW-05).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253126
Report an extraction error
Are you the manufacturer?
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