Fully Automatic Electronic Blood Pressure Monitor Model KD-571, KD-7971
510(k) K093452
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093452 | Date23 Dec 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- Withdrawn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
- 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
This device is a Fully Automatic Electronic Blood Pressure Monitor, classified under FDA Product Code DXN. It is designed to measure systolic and diastolic blood pressure, as well as pulse rate, using a non-invasive method with an inflatable cuff wrapped around the upper arm. The monitor operates automatically, eliminating the need for manual inflation and deflation, and is intended for use by both medical professionals and individuals in home settings. Its functionality aligns with FDA’s cardiovascular specialty classification, ensuring compliance with regulatory standards for blood pressure measurement devices.
The KD-571 and KD-7971 models are supplied as reusable electronic devices, requiring no sterilisation for home or clinical use. Both models are classified as FDA Class II devices under Special 510(k) clearance (K093452) and are intended for adult use only. They adhere to FDA regulation 870.1130 and are intended for non-invasive blood pressure measurement without MRI compatibility restrictions. Storage conditions are not specified but should follow standard electronic device guidelines to maintain accuracy and functionality.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Andon KD-571/KD-7971 used for?
The KD-571 and KD-7971 are fully automatic electronic blood pressure monitors designed for non-invasive measurement of systolic and diastolic blood pressure, as well as pulse rate. They use an inflatable upper-arm cuff to provide accurate readings, making them suitable for both home use by individuals and clinical settings by healthcare professionals. The device aligns with FDA cardiovascular standards for blood pressure measurement.
Are the KD-571 and KD-7971 single-use or reusable?
Both models are reusable electronic devices. They do not require sterilization for use in either home or clinical environments, simplifying maintenance and reducing waste. The manufacturer specifies no special sterilization procedures, allowing for repeated use as long as standard electronic device care guidelines are followed.
What age group is the KD-571/KD-7971 intended for?
These monitors are intended exclusively for adult use. The design and specifications do not accommodate pediatric or infant measurements, so they are not suitable for younger patients. Always ensure the correct cuff size is selected for accurate readings in adult patients.
How should the KD-571/KD-7971 be stored?
While specific storage conditions are not detailed, the device should be stored according to standard guidelines for electronic medical devices to preserve accuracy and functionality. This includes keeping it in a dry environment, away from extreme temperatures, direct sunlight, and sources of electromagnetic interference. Avoid storing it in damp or humid areas to prevent potential damage.
What regulatory clearance does the KD-571/KD-7971 have?
The KD-571 and KD-7971 are classified as FDA Class II devices under Special 510(k) clearance with the reference number K093452. They are substantially equivalent to a predicate device and comply with FDA regulation 870.1130 for non-invasive blood pressure measurement. The device was reviewed by the FDA’s Cardiovascular Advisory Committee.