(144 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and its validation against established standards (ISO 81060-2). There is no mention of AI, ML, or any advanced algorithms beyond the standard oscillometric method for analyzing pressure signals.
No.
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements for monitoring health conditions, not for providing therapy or treatment.
No
The "Intended Use / Indications for Use" explicitly states: "The Subject device is not intended to be diagnostic device."
No
The device description explicitly states that the device has "main components of the Blood Pressure Monitor are the main unit and cuff unit," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Subject device is not intended to be diagnostic device."
- Nature of Measurement: The device measures physical parameters (blood pressure and pulse rate) using a non-invasive technique (oscillometric method with a cuff). IVD devices typically analyze samples taken from the body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, while it's a medical device used for monitoring health parameters, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).
The Subject device is not intended to be diagnostic device.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The device has four series : U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) , U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) and U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ).
All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification.
Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
over the age of 12
Intended User / Care Setting
medical facilities or at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation study, 92 subjects, The test result show that the Upper Arm Electronic Blood Pressure Monitor meets the requirement of IEC 80601-2-30:2018 and ISO 81060-2:2018+A1(2020).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ±3mmHg; Pulse: ±5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 21, 2025
Shenzhen Urion Technology Co.,Ltd. Janice Ou Regulation Manager Floor 4-6th of Building D. Jiale Science & Technology Indust rial Zone, No.3, Chuang Wei Road, Heshuikou Community, MaTi Shenzhen, Guangdong 518106 China
Re: K243115
Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 30, 2024 Received: January 21, 2025
Dear Janice Ou:
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.
1
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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-device-safety/medical-device-reportingmdr-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
2
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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Stephen C. Browning -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K243115
Device Name
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N,U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
Indications for Use (Describe)
intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).
The Subiect device is not intended to be diagnostic device.
Type of Use (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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4
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | Feb. 20th, 2025 |
|---|---|
| Manufacturer information | Submitter's Name: Shenzhen Urion Technology Co.,Ltd |
| Address: Floor 4-6th of Building D, Jiale Science & | |
| Technology Industrial Zone, No.3, Chuang Wei Road, | |
| Heshuikou Community, MaTian Street, GuangMing New | |
| District, 518106 Shenzhen, PEOPLE'S REPUBLIC OF | |
| CHINA |
Contact person: Joanna Guo
TEL: (+86) -755-29231308
FAX: (+86) -755-29231308
E-Mail: Joanna@urionsz.com |
| Submission
Correspondent | Contact person: Miss Janice Ou
E-Mail: 411070313@qq.com |
2 Device Information
| Common name of
| the device | System, Measurement, Blood-Pressure, Non-Invasive |
|---|---|
| Trade name of the | |
| device | Upper Arm Electronic Blood Pressure Monitor |
| Type/Model of the | |
| device | U87Y series (models including U80Y, U81Y, |
| U82Y,U83Y,U86Y U80N, U81NH), U86E series (including | |
| U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), | |
| U81X series (including U81X, U80X, U82X, U83X, U81D, | |
| U82D, U83D, U81RH, U82RH) and U83Z series (including | |
| U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) | |
| Classification | |
| information | Classification panel: Cardiovascular |
| Classification name: System, Measurement, Blood- | |
| Pressure, Non-Invasive | |
| Regulation Number: 870.1130 | |
| Device Class: II | |
| Product Code: DXN |
5
510(k) type of Traditional submission
3 Predicate Device Information
| Sponsor: | Shenzhen Urion Technology Co.,LTD |
|---|---|
| Device: | Electronic Blood Pressure Monitor |
| 510(K) Number: | K160019 |
4 Device Descriptions
The device has four series : U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) , U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) and U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ).
All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification.
Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220
6
and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.
5 Intended Use/ Indications for Use
intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).
The Subject device is not intended to be diagnostic device.
6 SE Comparison
| Device
Name | Upper Arm Electronic Blood
Pressure Monitor | Electronic Blood Pressure
Monitor | NA |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Device
Model | U87Y series (including
U80Y,U81Y,U82Y,U83Y,U86Y,U8
0N,U81NH), U86E series
(including U82E, U80E, U80EH,
U81E, U83E, U85E, U80L,
U87E ), U81X series (including
U81X, U80X, U82X, U83X, U81D,
U82D, U83D, U81RH, U82RH)
and U83Z series (including U83Z,
U80Z, U81Z, U82Z, U85Z, U86Z
and U87Z) | U80 series, including U80A,
U80AH, U80B, U80BH | NA |
| Manufactu
rer | Shenzhen Urion Technology
Co.,LTD | Shenzhen Urion
Technology Co.,LTD | NA |
| Intended
Use/
Indication
for Use | The subject device intended to
measure the diastolic, systolic
blood pressures and pulse rate of
an adult individual who over the
age of 12 in medical facilities or at
home by using a non-invasive
oscillometric technique with a
single upper arm cuff (22-42 cm).
The Subject device is not
intended to be diagnostic device. | The U80 Series Upper Arm
Electronic Blood Pressure
Monitor is intended to
measure the systolic and
diastolic blood pressure as
well as the pulse rate of
adult person via non-
invasive oscillometric
technique in which an
inflatable cuff is wrapped
around the upper arm. It
can be used at medical
facilities or at home. The
intended upper arm
circumference is 22-
36cm.Suitable for adults
who over the age of 12. | Same |
| Intended
Population | Adult person over 12 | Adult person over 12 | Same |
| Intended
Anatomical
Site | upper arm | upper arm | Same |
Table 1. Substantial Equivalence Comparison
7
| Prescriptio
| n & OTC | OTC | OTC | same |
|---|---|---|---|
| Working | |||
| Principle | Oscillometric method | Oscillometric method | same |
| Pressuriza | |||
| tion | |||
| Source | Automatic internal pump | Automatic internal pump | same |
| Power | |||
| supply | Four AA or AAA batteries or AC | ||
| adapter | Four AA batteries or AC | ||
| adapter | Similar | ||
| Note 01 | |||
| Cuff Size | 220mm~420mm | 220mm~360mm | Similar |
| Note 02 | |||
| Measuring | |||
| range | 0-299mmHg(0-39.9KPa) | 0-299mmHg(0-39.9KPa) | Same |
| SYS:50 to 255mmHg | |||
| DIA: 30 to 200 mmHg | |||
| Pulse: 40 to 199 beat/minute | SYS:50 to 255mmHg | ||
| DIA: 30 to 200 mmHg | |||
| Pulse: 40 to 199 | |||
| beat/minute | |||
| Irregular | |||
| heart beat | |||
| prompt | |||
| function | Yes | Not publicly available | Different |
| Note 03 | |||
| Measuring | |||
| resolution | 1 mmHg | 1 mmHg | same |
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±3mmHg; Pulse | |
| ±5%. | same | ||
| Operating | |||
| Environme | |||
| nt | 5~40°C, | 10~40℃, | Similar |
| Note 04 | |||
| 15%~85%RH | 15%~93%RH |
Note 01: Both the subject device and the predicate device are powered by batteries and AC adapter. The difference is some modes for the subject device are powered by AAA batteries. The subject device comply with the requirement of standard IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2 and IEC 80601-2-30. This difference will not cause any safety or performance issue.
Note 02: The subject devices have the larger arm circumference than predicate device. 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.
Note 03: Irregular heart beat prompt does not influence the accuracy, and this function has been verified by performance testing. So the difference will not raise safety or effectiveness issue.
Note 04: There's a little difference on the operating environment. The measuring rage has been validated on the claimed operating environment for the subject device. The difference does not raise any issues concerning safety and effectiveness.
The subject device is as same as predicate device in Working Principle, Intended patient population, intended application site, measuring accuracy. Only their cuff size,
8
power supply and operating environment are a little bit different. However, the differences would not raise any safety or effectiveness issue based on tests in this submission.
7 Brief discussions of the non-clinical tests
Performance testing:
The subject device conforms to the following guidances and standards:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for A basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirement for A basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 80601-2-30: Medical electrical equipment-Particular requirements for basic A and essential performance of of automated non-invasive safety sphygmomanometers.
- A IEC 60601-1-11: 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
Biocompatibility testing:
The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk management process ". The biocompatibility testing includes the following tests:
- A Cytotoxicity
- A Sensitization
- A Irritation
8 Brief discussions of clinical tests
This monitor is clinically investigated according to the requirements of ISO 81060-2-2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. In the clinical validation study, the cuff were tested for clinical accuracy with the main unit, 92 subjects were used for determination of blood
9
pressure for each cuff.
The age range of subjects was over 12 years old;
Among the 92 subjects, at least 30% were male and at least 30% were female.
Hypertensive patients were also included in clinical testing. Pregnant women were not included in clinical testing.
The test summary of clinical validation: no safety problems and adverse events were found during the clinical test. The test result show that the Upper Arm Electronic Blood Pressure Monitor meets the requirement of IEC 80601-2-30:2018 and ISO 81060-2:2018+A1(2020).
9 Other information (such as required by FDA guidance)
No other information.
10 Conclusions
The subject device: Upper Arm Electronic Blood Pressure Monitor manufactured by Shenzhen Urion Technology Co., Ltd is respectively substantially equivalent to the predicate device (K160019).