(182 days)
Not Found
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components.
No
A therapeutic device is used to treat a disease or condition. This device is a blood pressure monitor, which is used for measurement and monitoring, not for treatment.
Yes
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate," which are parameters used to diagnose or monitor conditions related to blood pressure.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, LCD, and electronic interface module, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The KD-768 Wrist Measurement Electronic Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the wrist. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
The description clearly states it's a "non-invasive blood pressure measurement system" and that it uses a cuff wrapped around the wrist. This aligns with the definition of a medical device used for physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The KD-768 Wrist Measurement Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with an air cuff buckled around one's wrist according to the instruction in the user's guide manual.
The KD-768 Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 120 times measuring result with the month, day and time of measuring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
except infants and unconscious people / adult
Intended User / Care Setting
medical professionals 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 tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.
Non-clinical tests coincide the following All non-clinical standards, including Electromagnetic Compatibility test.
IEC601-1 (1988)
Medical electrical equipment --- Part 1: General requirements for safety IEC601-1 (1988)
Amendment 2
IEC 60602-2-30: 1995
Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
JAN 5 2006
K05/847
510(k) Summary
Identification of the submitter:
| Submitter: | Kodon (Tianjin) Electronic & Electrical Apparatus
Co., LTD
No 31, Changjiang Road, Nankai District, Tianjin,
P.R. China, 300193 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone number: | 86-22-6052 6082 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 07/05/2005 |
Identification of the product:
| Device proprietary Name: | KD-768 Wrist Measurement Electronic Blood
Pressure Monitor |
|--------------------------|-------------------------------------------------------------------------------|
| Common name: | Noninvasive blood pressure measurement
systems |
| Classification name: | Noninvasive blood pressure measurement system
Class II per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number | |
|---|---|---|---|
| KD-726 | Kodon (Tianjin) Electronic and | ||
| Electrical Co., Ltd. |
Device description:
KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 120 times measuring result with the month, day and time of measuring.
Intended use:
KD-768 Wrist Measurement Automatic Electronic Blood Pressure Monitor is
page 1 of 2
1
intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with an air cuff buckled around one's wrist according to the instruction in the user's guide manual.
Comparison of technological characteristics of new device to predicate devices:
The design of KD-768 Wrist Measurement Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a air cuff automatically inflated and released by an internal pump over the wrist to obtain blood pressure signals in the same manner as the predicate device.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.
Non-clinical Tests:
tests coincide the following All non-clinical standards, including Electromagnetic Compatibility test.
IEC601-1 (1988)
Medical electrical equipment --- Part 1: General requirements for safety IEC601-1 (1988)
Amendment 2
IEC 60602-2-30: 1995
Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977
page 2 of 2
2
Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of a circle with text around the perimeter. Inside the circle is a stylized image of a bird or abstract shape with three curved lines. The text around the circle is difficult to read due to the image quality.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 5 2006
Kodon (Tianjin) Electronic and Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi President No. 31 Changjiang Road Nankai District, Tianjin CHINA
Re: K051847
Trade Name: Kodon KD-768 Wrist Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 05, 2005 Received: December 05, 2005
Dear Mr. Yi:
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 (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Liu Yi
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) number:
Device name:
KD-768 Wrist Measurement Automatic Electronic Blood Pressure Monitor
Indications for use:
The KD-768 Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
Prescription Use
AND/OR
Over-The-counter Use YES
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Bhummon
510(k) Number