KOROT Blood Pressure Monitor (KOROT P3 Accurate)

K250091 · Korot Co., Ltd. · DXN · Mar 14, 2025 · Cardiovascular

Device Facts

• Record ID: K250091
• Device Name: KOROT Blood Pressure Monitor (KOROT P3 Accurate)
• Applicant: Korot Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 14, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

Device Story

KOROT P3 Accurate is a digital non-invasive blood pressure (NIBP) monitor for adult use. Device utilizes both oscillometric and automated auscultation methods to measure systolic/diastolic blood pressure and pulse rate. Input consists of blood flow oscillations and Korotkoff sound signals captured via an upper arm cuff. Device inflates cuff above systolic pressure, then slowly releases, electronically processing signals to compensate for movement and external noise. Output is displayed to the user; Bluetooth connectivity allows data transmission to a KOROT program for storage. Used in clinical or home settings; operated by patients or healthcare providers. Provides health status information for both hypertensive and non-hypertensive individuals. Benefits include combining auscultation accuracy with automated convenience.

Clinical Evidence

Clinical data collected to validate the expanded upper arm circumference range (42-52 cm). Totality of clinical data across the full 22-52 cm range supports the device's performance claims. Bench testing conducted per applicable standards to support equivalence and modifications.

Technological Characteristics

Digital NIBP monitor; oscillometric and automated auscultation sensing principles. Includes upper arm cuffs (KR-CGM01, KR-CGL01, KR-CGML1, KR-CGXL1, KR-CDM01, KR-CDL01, KR-CDML1). Features Bluetooth connectivity for data transmission (not for active monitoring).

Indications for Use

Indicated for measuring systolic/diastolic blood pressure and pulse rate in adult patients with upper arm circumferences between 22 cm and 52 cm.

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 (K221764)

Submission Summary (Full Text)

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March 14, 2025

Korot Co. Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K250091

Trade/Device Name: KOROT Blood Pressure Monitor (KOROT P3 Accurate) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 13, 2025 Received: March 13, 2025

Dear Dave Yungvirt:

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.

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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 (OS) 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 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-device-advicecomprehensive-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-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/medicaldevices/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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K250091

Device Name Blood Pressure Monitor (KOROT P3 Accurate)

Indications for Use (Describe)

This blood pressure monitor is designed to measure blood pressure (diastolic and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| Prepared on: 2025-03-12 | | |
|------------------------------------|----------------------------------------------------------------------------------|--------------|
| 510(k)#: K250091 | | |
| Contact Details | | |
| Applicant Name | KOROT Co., Ltd. | |
| Applicant Address | 1-102, 330, Yeongok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, | |
| | 31026 Korea, South | |
| Applicant Contact telephone | 827040166745 | |
| Applicant Contact | Mr. Muyeol Lee | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | |
| Device Trade Name | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | |
| Common Name | Noninvasive blood pressure measurement system | |
| Classification Name | System, Measurement, Blood-Pressure, Non-Invasive | |
| Regulation Number | 870.1130 | |
| Product Code(s) | DXN | |
| Legally Marketed Predicate Devices | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K221764 | Blood Pressure Monitor | DXN |

## Device Description Summary

The KOROT P3 Accurate is a digital monitor intended for use in measuring blood pressure and pulse rate in adults with upper arm circumference ranging from 22cm (9-inch to 20-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The KOROT P3 Accurate may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.

Blood pressure is the measurement of pressure of blood vessels. Blood vessels. Blood pressure can be measured by direct or indirect measurement supports indirect measurement using cuff. This equipment tracks and analyzes the blood flow oscillations under the pressure using the highest to the lowest pressure as shown by the figure below when the minute pressure speed is determined by the heartbeat. This equipment adopts Oscillometric method and automated auscultation method using a cuff for blood pressure measurement. In case of Oscilometric method, the device determines the systolic, diastolic and pulse rate on the blood flow oscillations measured through the cuff. On the other hands, in case of Auto auscultation method that combines the accuracy of auscultation, which is regarded as the gold standard for blood pressure measurement. To measure the blood pressure, wap the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the Korotkoff sound signal and the pressure sensor signal, which you can catch with the sensor attached to the cuff, to measure the systolic blood pressure. The Automated Auscultation applied to KOROT P3 Accurate combines the accuracy of the auscultation method staffs hear directly with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement.

*Cuffs: KR-CGM01, KR-CGL01, KR-CGML1, KR-CGXL1, KR-CDM01, KR-CDL01, KR-CDML1

* Bluetooth is only used to transmit data from the device to KOROT program and not used for active patient monitoring

## Intended Use/Indications for Use

This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

#### Indications for Use Comparison

The indications for use is identical except the range of arm circumference. So, we performed additional validation the range of 42 to 52cm.

## Technological Comparison

All the modifications were verified with rationales and we concluded that the substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. The device has the same technological characteristics with the predicate device except the modifications below;

- Expansion of the arm circumference range (22cm~52cm)

- Addition of Bluetooth
- GUI change
- Addition of functions
- Component change
- Improved pulse accuracy
- Improved data storage
- Transport/Storage condition change

## Non-Clinical and/or Clinical Tests Summary & Conclusions

For non-clinical test, all necessary bench testing were conducted on the subject device to support the determination of substantial equivalence to the predicate device. Not only the same standards and methods which are used to support the predicate device, but also the additional standards and methods were used for the subject device to support the equivalence and modifications. For clinical test, the additional clinical data were collected for the extra range of the upper arm circumference and the totality of the clinical data from 22 to 52 cm supported the device's claim of being applicable to patients with upper arm circumference

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