(249 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of such technologies.
No.
The device is described as an "Automatic Blood Pressure Recording Device" that "measures pulse rate" and is a "non-invasive electronic sphygmomanometer." Its purpose is to derive blood pressure and measure pulse rate, which are diagnostic measurements, not therapeutic interventions.
No
Explanation: The device is described as an "Automatic Blood Pressure Recording Device" that measures blood pressure and pulse rate. While it provides data points, it does not explicitly state that it is used to diagnose a medical condition, but rather to derive pressure values.
No
The device description explicitly states it is an "Automatic Blood Pressure Recording Device" and a "non-invasive electronic sphygmomanometer," which are hardware devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Ueda Udex Super BP-2000 is a non-invasive device that measures blood pressure and pulse rate directly from the patient's body. It does not analyze any biological specimens.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device rather than an IVD.
N/A
Intended Use / Indications for Use
The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate.
This device is for use by adult population ( 18 years and older.)
This is a non-invasive electronic sphygmomanometer.
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adult population ( 18 years and older.)
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Yolanda Smith Requlatory Affairs Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K993316 Trade Name: UEDA UDEX Super BP-2000 Automatic Blood Pressure Requlatory Class: II (two) Product Code: DXN March 13, 2000 Dated: Received: March 14, 2000
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, . FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page - Ms. Yolanda Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4648. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Brian E. Aumeym
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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K9933316 510(k) Number (if known):
Device Name: Udex Super BP-2000
Indications for Use:
The Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate.
This device is for use by adult population ( 18 years and older.)
This is a non-invasive electronic sphygmomanometer.
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K993316
(PLEASE DO NOT WRITE BELOW THIA LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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