Fully Automatic Electronic Blood Pressure Monitor KD-5902
510(k) K083317
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083317 | Date29 Jan 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Fully Automatic Electronic Blood Pressure Monitor, Model Kd-5902
- 510(k) Number
- FDA Product Code
- DXN
- FDA applicant
- Andon Health Co, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The KD-5902 is a fully automatic electronic blood pressure monitor, classified as a noninvasive blood pressure measurement device. It measures systolic, diastolic, and mean arterial pressure using transducers applied to the arm. The device is designed for home or clinical use to provide accurate and reliable blood pressure readings without manual intervention. Its automated operation ensures consistency in measurements, reducing user error.
This device is supplied as a single-use or reusable unit, depending on manufacturer guidelines, and is intended for use in both home and clinical settings. It features 60 memory slots for storing readings, along with date and time tracking, and includes an irregular heartbeat detection function. The KD-5902 operates under FDA clearance (510K, K083317) and adheres to regulatory standards for noninvasive blood pressure monitors. Storage and handling should follow manufacturer instructions to maintain accuracy and functionality.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the KD-5902 used for?
The KD-5902 is a fully automatic electronic blood pressure monitor designed for noninvasive measurement of systolic, diastolic, and mean arterial pressure. It is intended for use in both home and clinical settings to provide consistent, reliable readings without manual intervention, reducing the risk of user error.
How is the KD-5902 supplied, and can it be reused?
The KD-5902 can be supplied as either a single-use or reusable unit, depending on the manufacturer’s guidelines. Reuse is permitted only if proper cleaning, disinfection, and maintenance procedures are followed to ensure accuracy and functionality. Always refer to the manufacturer’s instructions for specific handling and storage recommendations.
Does the KD-5902 include features for tracking readings?
Yes, the KD-5902 includes 60 memory slots to store blood pressure readings, along with automatic date and time tracking. This allows users to monitor trends over time and share data with healthcare providers if needed.
What safety features does the KD-5902 have?
The KD-5902 includes an irregular heartbeat detection function to alert users if an abnormal rhythm is detected during measurement. This helps ensure that readings are accurate and that potential cardiac irregularities are identified for further evaluation.
How should the KD-5902 be stored?
The KD-5902 should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture. Proper storage conditions help maintain the device’s accuracy and functionality. Always follow the manufacturer’s instructions for storage to avoid damage or calibration issues.