← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K083318 # FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 (K083318) _Andon Health Co, Ltd. · DXN · Jan 29, 2009 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K083318 ## Device Facts - **Applicant:** Andon Health Co, Ltd. - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Jan 29, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Intended Use KD-5904 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 of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device. ## Device Story Oscillometric non-invasive blood pressure monitor; utilizes silicon integrated pressure sensor to detect arterial oscillations. Input: pneumatic pressure signals from upper arm cuff (22-48cm). Processing: microprocessor (H8/38124) analyzes signals to calculate systolic/diastolic pressure and pulse rate. Output: digital values displayed on LCD. Operation: 6-button interface (Start, Memory, Mode, Voice, M+, M-) for user control. Used by medical professionals or patients at home. Provides objective blood pressure data to assist in clinical monitoring and hypertension management. ## Clinical Evidence Bench testing only. Device performance validated against ANSI/AAMI SP-10 standard for non-invasive blood pressure measurement systems. Electrical safety and electromagnetic compatibility verified per EN60601-1 and EN60601-1-2. ## Technological Characteristics Oscillometric measurement method; silicon integrated pressure sensor; H8/38124 microprocessor; LCD interface; 6-button control; cuff circumference 22-48cm. Standards met: ANSI/AAMI SP-10, EN60601-1 (General safety), EN60601-1-2 (EMC). ## Regulatory 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 - KD-595 ([K070828](/device/K070828.md)) ## Related Devices - [K083246](/device/K083246.md) — FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 · Andon Health Co, Ltd. · Jan 29, 2009 - [K083317](/device/K083317.md) — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 · Andon Health Co, Ltd. · Jan 29, 2009 - [K110330](/device/K110330.md) — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR · Andon Health Co, Ltd. · Feb 18, 2011 - [K234041](/device/K234041.md) — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) · Andon Health Co, Ltd. · Apr 22, 2024 - [K083395](/device/K083395.md) — SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 · Andon Health Co, Ltd. · Feb 27, 2009 ## Submission Summary (Full Text) {0}------------------------------------------------ 510(k) Summary # JAN 2 9 2009 #### ldentification of the submitter: Submitter: Fax number: Contact: Telephone number: Date of Application: Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 86-22-6052 6162 Liu Yi 10/29/08 #### Identification of the product: Device proprietary Name: 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-595 | Andon Health Co., Ltd | K070828 | ### Device description: KD-5904 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm, the device can analyze the signals promptly and display the test results. It has some other functions, such as 6 buttons for operation. #### Intended use: KD-5904 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 of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device. {1}------------------------------------------------ K083318 P2/2 # Summary comparing technological characteristics with predicate device: KD-5904 Fully Automatic Electronic Blood Pressure Monitor has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD. The modifications that were made are: - 1. Appearance - 2. Change into 6 buttons for operation from original two buttons. 6 buttons include<START>,<MEMORY>,<MODE>,<VC>,<M+>,<M->. Pressing <START>: turn on the device and measure/turn off the device: Pressing<MEMORY>: begin memory and browse the item: Pressing<MODE>: begin to adjust the time, press <M+> to increase, press <M-> to decrease. Pressing <VC>: turn on /turn off the voice. - 3. Larger cuff (cuff circumference is limited to 22cm-48cm). 4. Change microprocessor from MB89485 to H8/38124. Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device. | FDA file reference number | 510K# K070828 | |-------------------------------|-------------------| | Technological Characteristics | Comparison result | | Indications for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Identical | | Performance | Identical | | Sterility | Not Applicable | | Biocompatibility | Identical | | Mechanical safety | Identical | | Chemical safety | Not Applicable | | Energy used and/or delivered | Identical | | Where used | Identical | | Standards met | Identical | | Electrical safety | Identical | ## Device testing: KD-5904 Fully Automatic Electronic Blood Pressure Monitor meets the following standards: - . ANSI/AAMI SP-10 standard - EN60601-1 Medical electrical equipment Part 1: General requirements for safetv - EN60601-1-2 Electromagnetic Compatibility {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 9 2009 Andon Health Co., Ltd. c/o Ms. Liu Yi No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Re: K083318 Trade/Device Name: KD-5904 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: December 19, 2008 Received: December 29, 2008 Dear Ms. 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 - Ms. Liu Yi 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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, h Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510K submission for KD-5904 Fully Automatic Electronic Blood Pressure Monitor # (083319 # Statement of Indications for Use **510(k) Number:** k083318 Andon Health Co., Ltd Applicant: Device name: #### KD-5904 Fully Automatic Electronic Blood Pressure Monitor ## Indications for use: KD-5904 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-48cm. 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) (Division Sidh-Off) Division of Cardiovascular Devices 4083316 510(k) Number Page 1 of - 9 - --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K083318](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K083318) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K083318