510(k) · Cleared
ClearedUpper arm electronic blood pressure monitor (XB-01)
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 3, 2026 as substantially equivalent to K240832 (Guangdong Transtek Medical Electronics Co., Ltd., 2024) and 1 other predicate after a 251-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Jun 3, 2026
- Review
- 251 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K052153 (2005). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 4 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 3 generations backK133383 HEM-7320Omron Healthcare, Inc. · 2014
- 2 generations backK170605 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2018
- 1 generation backK200939 Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2020
- This deviceK253124 Upper arm electronic blood pressure monitor (XB-01)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 |
|---|---|---|---|---|---|
| −5 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −4 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −3 | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| −2 | K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood… | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018 | — |
| −1 | K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020 | — |
| 0 (this device) | K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K240832 | Blood Pressure Monitor (BBZ32-AA01)Summary page 6…K253124 Page 1 of 7 510(k) Summary 510(k) number: K240832 4.0 Indication for Use Statement This upper arm electronic blood pressure monitor is used to measure the systolic blood pressur… | 2024 |
| * | K200939 | Electronic Blood Pressure MonitorSummary page 10…redicate Device Item Remark K200939 Max Cuff 290 mmHg 299mmHg pressure… | 2020 |
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 4.1 years on median.
- None of the 8 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. 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 upper arm electronic blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The electronic blood pressure monitor adopts the oscillographic measurement method, inflates the cuff, detects the blood flow of the brachial artery in the upper arm, and then converts your blood pressure into a digital reading through the device. The device is simple and convenient to use, and patients can…
Read the full statement (118 words)
This upper arm electronic blood pressure monitor is used to measure the systolic blood pressure, diastolic blood pressure and pulse rate of adults. The electronic blood pressure monitor adopts the oscillographic measurement method, inflates the cuff, detects the blood flow of the brachial artery in the upper arm, and then converts your blood pressure into a digital reading through the device. The device is simple and convenient to use, and patients 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 as stated in the FDA summary.
https://510kreport.com/device/K253124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253124: Upper arm electronic blood pressure monitor (XB-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253124
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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