(21 days)
No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI/ML terms or capabilities.
No
These devices are intended for monitoring and displaying blood pressure and pulse rate, which are measurements for diagnostic and monitoring purposes, not for active treatment or prevention of disease.
Yes
This device is intended to monitor and display blood pressure and pulse rate, which are physiological parameters used to assess a person's health status. The information gathered can be used by medical professionals or at home to identify potential health issues or abnormalities, thus serving a diagnostic purpose.
No
The device description explicitly mentions hardware components such as an air cuff, internal pump, LCD, and electronic interface module, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, neither of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc.
- These blood pressure monitors are non-invasive devices. They measure physiological parameters (blood pressure and pulse rate) directly from the body using a cuff. They do not analyze any bodily fluids or tissues.
The descriptions clearly state that these devices are used to measure blood pressure and pulse rate by wrapping a cuff around the arm or wrist. This is a direct measurement from the body, not an analysis of a specimen.
N/A
Intended Use / Indications for Use
KD-575 Memory 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.
The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
Product codes
DXN
Device Description
KD-575 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 devise 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. It can storage and show 120 times measuring result with the month, day, time of measuring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left upper arm, wrist
Indicated Patient Age Range
except infants and unconscious people, over age 18
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 All Electromagnetic Compatibility test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K042581
p1/2
510(k) Summary
OCT 1 3 2004
Identification of the submitter:
Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-60526082 Telephone number: Fax number: 86-22-60526162 Liu Yi Contact: 08/25/04 Date of Application:
Identification of the product:
| Device proprietary Name: | KD-575 Memory 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-559 | Kodon (Tianjin) Electronic and Electrical | |
| Apparatus Co., Ltd. | K030358 |
Device description:
KD-575 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 devise 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. It can storage and show 120 times measuring result with the month, day, time of measuring.
Intended use:
i
1
KD-575 Memory 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-575 Memory Automatic Electronic Blood Pressure Monitor can storage and show 120 times measuring results with the month, day, time of measuring. It can help patients to memorize the measuring data of their measuring results. Therefore the patients can analyze the measuring data and inspect their physical conditions. The time and the date are the advantages of KD-575 compare with 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:
standards, including tests coincide the following non-clinical All 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
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
OCT 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ya Horng Electronic Co., Ltd. c/o Dr Ke-Min Jen Cro Dr No Ninese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, TAIWAN 300 CHINA
Re: K042581
K042581
Trade Name: YA HORNG Automatic Digital Wrist Blood Pressure Monitor, AK-3000T
Trade Name: YA HORNG Automatic Case Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 18, 2004 Received: September 22, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainter in the the may are created in interests a referenced above and nave decemblied the arrised predicate devices marketed in interstate for use stated in the encrosule for legally manatos people of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Trug commerce prior to May 28, 1976, the enastinone with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval applications of the Act. The and Cosment Act (Act) that do not require app to the general controls provisions of the Act. The You may, merelore, market the devree, seejeer of use annual registration, listing of general controls provisions of the free herstand company.
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 If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Extrangemage of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I sacra. Its gas ...
publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Dr Ke-Min Jen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device of a forelocares . You must that FDA has made a decertification that your as res by other Federal agencies. You must a or any Federal statules and regulations daministed or registration and listing (21 little (21 l comply with all the Act S requirements, moradial was and one and security of the sent of CFR Part 807); labeling (21 CFR Part 001); good manager (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat (2); 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (becalons of to vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale there permi premarket nother in TDA miding of basemation 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 If you desire specific advice for your ac not one one one one one the regulation entitled, and Colliact the Office of Complanes at (301) 317 - 17 - 17 - 10 may obtain Misoranuiling of Icrerchee to premaintentibilities under the Act from the Division of Small other general Information on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Blinxlma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Ya Horng CO. LTD. The logo is in black and white, with the words "YA HORNG" in large, bold letters. Below that, in smaller letters, are the words "Ya Horng CO. LTD.". The logo is simple and easy to read.
No. 35. Zsha Lur Antin Shiang, Tainan, T Fax: 886-6-5935870 Tel: 886-6-5932201 E-mail: lab@yahorng.com http:// www.yahorng.com
Applicant: _ YA HORNG CO., LTD. 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________
YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Device Name: AK-3000T
Indications for use: .
The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
. Note:
Data Transmission: Connection to PC using RS232 cable.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
vision of Cardiovascular Devices
10(k) Number K042581