(118 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components.
No
The device measures blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
No
The device is described as a blood pressure monitor that measures systolic and diastolic blood pressures and pulse rate. While it provides physiological measurements, it is not explicitly stated as making a diagnosis or aiding in the diagnosis of a disease or condition. It monitors parameters, which can be part of diagnostic workup, but the device itself is not a diagnostic tool according to the provided text.
No
The device description explicitly mentions hardware components such as an inflatable cuff, internal pump, LCD, and electronic interface module, indicating it is not a software-only device.
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-525E Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by using a cuff wrapped around the upper arm. It does not analyze samples taken from the body.
The device description and intended use clearly indicate it's a non-invasive physiological measurement device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
KD-525E Fully 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 the air cuff around the left upper arm according to the instruction in the user's guide manual.
KD-525E Fully Automatic 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 upper arm. The cuff circumference is limited to 22cm-30cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-525E Fully Automatic Electronic 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 device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left upper arm
Indicated Patient Age Range
except infants and unconscious people / adult individual
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: Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
Non-clinical Tests: non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test, Product Safety test and Biocompatibility test.
IEC601-1-2: 2001
Medical electrical equipment-----Part 1-2:General requirements for safety; Collateral standards: Electromagnetic compatibility; Requirements and test.
IEC60601-1: 1998+A1:1991+A2:1995
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
ISO 10993-5
Biological evaluation of medical device --- part 5: Test for in vitro cytotoxicity.
ISO 10993-10
Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.
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.
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
510(k) Summary
JUN - 7 2007
ldentification of the submitter:
Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Telephone number: 86-22-6052 8012 86-22-6052 6162 Fax number: Liu Yi Contact: Date of Application: 29/01/07
Identification of the product:
| Device proprietary Name: | KD-525E Fully Automatic 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-622 | Kodon (Tianjin) Electronic and Electrical | |
| Apparatus Co., Ltd. | K030358 |
Device description:
KD-525E Fully Automatic Electronic 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 device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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.
Page 1 of 2
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Intended use:
KD-525E Fully 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 the air cuff around the left upper arm according to the instruction in the user's guide manual.
Comparison of technological characteristics of new device to predicate devices:
KD-525E Fully Automatic Electronic Blood Pressure Monitor is the basic of KD-622 Memory Automatic blood pressure monitor. KD-525E has a bump to inflate automatically. Comparing with KD-622 memory automatic blood pressure monitor, KD-525E has no memory function.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
Non-clinical Tests:
non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test, Product Safety test and Biocompatibility test.
IEC601-1-2: 2001
Medical electrical equipment-----Part 1-2:General requirements for safety; Collateral standards: Electromagnetic compatibility; Requirements and test.
IEC60601-1: 1998+A1:1991+A2:1995
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
ISO 10993-5
Biological evaluation of medical device --- part 5: Test for in vitro cytotoxicity.
ISO 10993-10
Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human figures. The figures are interconnected, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2007
Kondon (Tianiin) Electonic & Electrical Apparatus Co., LTD c/o Mr. Liu Yi President of the Board of Directors, No. 31 Changjiang Road, Tianjin, PR CHINA 3000193
Re: K070395
KD-525E Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 21, 2007 Received: May 21, 2007
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimimor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number ( if known): _
KD702395
Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD Applicant:
KD-525E Fully Automatic Electronic Blood Pressure Device name: Monitor
Indications for use:
KD-525E Fully Automatic 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 upper arm. The cuff circumference is limited to 22cm-30cm.
Prescription use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use YES (21 CFR 807 Subpart C)
( PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
ular Devices 101k) Number
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