Fully Automatic Electronic Blood Pressure Monitor
by Andon Health Co., Ltd. 17 variants
510(k) K183534
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183534 | Date16 May 2019 | 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- Withdrawn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 (Product Code: DXN), classified as a non-invasive blood pressure measurement system. It is designed to automatically measure and display both systolic and diastolic blood pressure readings without manual inflation of the cuff. The monitor operates electronically, providing accurate and convenient measurements for clinical or home use by trained personnel or individuals.
The monitors are supplied as reusable devices intended for repeated use in clinical or home settings. They comply with FDA 510(k) clearance (K183534) under the Cardiovascular (CV) advisory committee and are classified as Class II under Special Controls. No specific sterility or MRI safety information is provided in the data, and storage conditions are not detailed beyond standard manufacturer guidelines. The device models (KD-753, KD-738BR, KD-733) are explicitly listed as part of the authorized submission.
Other devices from Andon Health Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Andon KD-753 used for?
The Andon KD-753 is a fully automatic electronic blood pressure monitor designed to measure and display both systolic and diastolic blood pressure readings automatically. Unlike manual devices, it eliminates the need for manual cuff inflation, providing convenient and accurate measurements for clinical or home use by trained personnel or individuals.
How is the Andon Fully Automatic Electronic Blood Pressure Monitor supplied?
The device is supplied as a reusable system, intended for repeated use in clinical or home settings. This design ensures durability and cost-effectiveness over time, as it does not require single-use components or disposable parts.
Are the Andon models KD-753, KD-738BR, and KD-733 interchangeable?
Yes, these models (KD-753, KD-738BR, and KD-733) are explicitly listed as part of the same FDA-authorized submission (K183534). While they may share core functionality, users should verify specific features, cuff sizes, or software compatibility in the manufacturer’s instructions to ensure proper operation for their intended use.
Is sterility a requirement for the Andon Fully Automatic Electronic Blood Pressure Monitor?
The provided data does not specify any sterility requirements for this device. Since it is classified as reusable and intended for clinical or home use, standard cleaning and disinfection protocols (as outlined by the manufacturer) should be followed to maintain hygiene and prevent cross-contamination.
What regulatory pathway does the Andon Fully Automatic Electronic Blood Pressure Monitor follow?
The device follows the FDA’s 510(k) clearance pathway, specifically under the Cardiovascular (CV) advisory committee. It was granted clearance (K183534) as substantially equivalent to a predicate device, classified under Class II with Special Controls. This pathway ensures compliance with U.S. regulatory standards for non-invasive blood pressure measurement systems.