Upper arm electronic blood pressure monitor (XB-01)
Device Facts
| Record ID | K253124 |
|---|---|
| Device Name | Upper arm electronic blood pressure monitor (XB-01) |
| Applicant | Shenzhen Ziqing Medical Equipment Co., Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Upper arm electronic blood pressure monitor (XB-01) uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Device consists of main unit, cuff, and lithium battery. User wraps cuff around upper arm; device automatically inflates, detects brachial artery blood flow, and converts signals to digital readings. Features include 2x99 memory storage, average of last 3 readings, optional voice broadcast, and automatic shutdown. Used by patients for self-measurement or in medical settings. Output displayed on LED screen; assists in monitoring blood pressure trends. Safety features include 290 mmHg maximum pressure limit.
Clinical Evidence
Clinical validation performed per ISO 81060-2:2018. Study included 87 subjects. Auscultation using a calibrated mercurial sphygmomanometer served as the gold standard control. Results demonstrated accuracy within ±3 mmHg, meeting ISO 81060-2 requirements. No adverse effects or complications reported.
Technological Characteristics
Oscillometric measurement principle. Materials: non-woven fabrics and PVC (ISO 10993 compliant). Power: 3.7V 750mAh lithium battery. Display: LED. Connectivity: None. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30.
Indications for Use
Indicated for non-invasive monitoring of systolic blood pressure, diastolic blood pressure, and pulse rate in adults (18 years and above) in home and medical environments. Not for use as the sole basis for clinical diagnosis.
Regulatory Classification
Identification
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
Predicate Devices
- Blood Pressure Monitor (BBZ32-AA01) (K240832)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 3, 2026
Shenzhen Ziqing Medical Equipment Co., Ltd.
% Boyle Wang
General manager
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai, 200120
China
Re: K253124
Trade/Device Name: Upper arm electronic blood pressure monitor (XB-01)
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive blood pressure measurement system
Regulatory Class: Class II
Product Code: DXN
Dated: May 19, 2026
Received: May 19, 2026
Dear Boyle Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled 'Deciding When to Submit a 510(k) for a Change to an Existing Device'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
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K253124 - Boyle Wang
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(https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K253124 - Boyle Wang
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Sincerely,
**JENNIFER W. SHIH -S**
for LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K253124
?
Please provide the device trade name(s).
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Upper arm electronic blood pressure monitor (XB-01)
Please provide your Indications for Use below.
?
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.
Please select the types of uses (select one or both, as applicable).
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
?
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510(k) Summary
# 510(k) Summary
## K253124
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
### 1.0 Submitter's Information
Name: Shenzhen Ziqing Medical Equipment Co., Ltd.
Address:201, Building 2, No.1 Chuangye Road, Shijing
Community, Shijing Street, Pingshan District, Shenzhen, China
Tel: +86-13612876322
Contact: Chen Yongsheng
### Designated Submission Correspondent
Contact: Mr. Boyle Wang
Name: Shanghai Truthful Information Technology Co., Ltd.
Address: Room 1801, No. 161 East Lu Jiazui Rd., Pudong,Shanghai,
200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
Date of Preparation: May.19,2026
### 2.0 Device Information
Trade name: Upper arm electronic blood pressure monitor
Common name: Noninvasive Blood Pressure Measurement System
Classification name: Noninvasive Blood Pressure Measurement System
Model(s): XB-01
Production code: DXN
Regulation number: 21 CFR 870.1130
Classification: Class II
Panel: Cardiovascular
### 3.0 Predicate Device Information
Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.
Trade/Device name: Blood Pressure Monitor (BBZ32-AA01)
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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 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.
#### **5.0 Device Description**
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.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
Stores measurement records (including date, time, SYS, DIA, and PUL) for each user. 2x99 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x99 sets. Enables viewing of memory records and average values of the last 3 measurements (when records $\geq 3$) via the 'Memory' button. Supports deletion of all memory records for a selected user.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.
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510(k) Summary
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
There is a maximum pressure safety setting at 290 mmHg, monitors pressure levels during inflation (up to 290 mmHg) and triggers deflation upon reaching optimal measurement pressure.
Automatic shutdown after 60 seconds of inactivity.
The device includes model XB-01. It is composed of a main unit, a cuff, and a lithium battery.
## 6.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-11:2020, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
- FDA guidance: Content of Premarket Submissions for Device Software Functions, dated July 20, 2023
## 7.0 Clinical Test Conclusion
The clinical testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Arm Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 87 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer
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510(k) Summary---
used as control group for comparison with the subject device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3 mmHg. No adverse effect and/or complication is found in this study. And the subject device comply with the standard requirements and the accuracy the manufacture declared.
### 8.0 Technological Characteristic Comparison Table
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510(k) Summary
Table1-General Comparison
| Item | Subject Device | Predicate Device K240832 | Remark |
| --- | --- | --- | --- |
| Manufacturer | Shenzhen Ziqing Medical Equipment Co., Ltd.. | Guangdong Transtek Medical Electronics Co., Ltd. | / |
| Product Name | Upper arm electronic blood pressure monitor XB-01 | Blood Pressure Monitor (BBZ32-AA01) | / |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Intended Use/Indication for Use | 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. | This Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm(about 8¾"-16½") or 22cm to 42cm(about 8¾"-16½"). It is intended for adult indoor use only. | Same |
| Application Site | Upper Arm | Upper Arm | Same |
| Arm Circumference | About 27.5-36.5cm | 22cm to 32cm (about 8¾"-12½") or 22cm to 42cm (about 8¾"-16½") | Different (1) |
| Patients Contacting Materials | Patient contact materials of the cuff:non-woven fabrics & PVC According to ISO-10993 | Allpatient contact parts meet the requirements of ISO-10993 | Same |
| Patient Population | Adults (18 years and above) | Adult | Same |
| Measurements Item | SYS,DYS,Pulse | Measuring systolic and diastolic blood pressure and pulse rate of intended population, including irregular pulse rhythm detection. | Different (2) |
| Display | LED liquid crystal display | LCD | Same |
| Design Method | Oscillometric Method | Oscillometric Method | Same |
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510(k) Summary
Table 2 Performance Comparison
| Item | Subject Device | Predicate Device K200939 | Remark |
| --- | --- | --- | --- |
| Max Cuff pressure | 290 mmHg | 299mmHg | Different (3) |
| BP Range | (0-38.7kPa)0-290mmHg | 0 ~ 299 mmHg; | |
| BP Accuracy | ±3 mmHg(+0.4kPa) | ±3mmHg (0.4kPa) | Same |
| PR Range | 40-180 beats/min | 40-199 beat/minute, ±5% | Different (4) |
| Pulse Accuracy | ±5% of reading value | ±5% | Same |
| Inflation Method | Automatic inflation | Automatic inflation | Same |
| Deflation Method | Automatic deflation | Automatic deflation | same |
| Memory Size | 2x99 | 2x99 | Same |
| Operation Condition | Temperature from + 5°C ~ + 40°C, humidity from 15% ~ 85% RH. Atmospheric pressure:(80~105)kPa | Temperature: 5°C~40°C; Relative Humidity: 15%~90% RH; Atmospheric:700hPa~1060hPa | Different (5) |
| Storage Condition | Temperature: (-20~ + 55) °C; humidity: ≤93% RH | Temperature: -20°C~60°C; Relative humidity≤93%RH, non-condensing; Atmospheric:500hPa~1060hPa | |
| Power Supply | Built-in lithium battery DC3.7V 750mah | 4*1.5V AAA batteries | Different (6) |
| Performance Standard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | Same |
Analysis:
1) The Measurements range of the subject device is within that of the predicate device. The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject.
The subject device has also been validated according to IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports,the difference here does not raise any issues concerning safety and effectiveness
2)The Measurements Item of the subject device is within that of the predicate device. The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject.
3) The Blood Pressure Range of the subject device has minor difference with the blood pressure range of predicate devices, the measuring rang of the subject device was validated according to ISO 80601-2-30, the difference does not raise different questions of safety and effectiveness.
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510(k) Summary---
4) The pulse rate of the subject device is within that of the predicate device. The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject.
5) All the differences in operation condition and storage/transportation condition don't affect the safety and effectiveness which is concluded after all the required testing, thus, this difference does not raise different questions of safety and effectiveness.
6) The difference in power source will not affect the safety and effectiveness of the subject device. IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 can demonstrate that the subject device can maintain the safety and performance. Thus, this difference does not raise different questions of safety and effectiveness.
**Table 3 Safety Comparison**
| Item | Proposed Device | Predicate Device K200939 | Remark |
| --- | --- | --- | --- |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Biocompatibility | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance | Same |
## 9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
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