KD-575 Memory Automatic Electronic Blood Pressure Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042418 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Kd-788 Wrist Measurement Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K052450 Active Cleared 28 Feb 2006

• Kd-726 Memory Wrist Automatic Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K030359 Active Cleared 6 Nov 2003

• Kd-525E Fully Automatic Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K070395 Active Cleared 7 Jun 2007

• Kd-795 Wrist Measurement Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K070826 Active Cleared 15 Aug 2007

• Kd-768 Wrist Measurement Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K051847 Active Cleared 5 Jan 2006

• Kd-595 Fully Automatic Electronic Blood Pressure Monitor

  Class II

  FDA 510(k) K070828 Active Cleared 15 Aug 2007

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• What types of settings is the KD-575 blood pressure monitor intended for, and how does its memory function benefit users?

  The KD-575 is designed for both clinical and home use to measure blood pressure non-invasively. Its memory function stores up to 120 readings, including systolic, diastolic pressure, date, and time, which helps clinicians track trends over time and patients monitor their cardiovascular health at home without manual note-taking.

• Is the KD-575 a single-use or reusable device, and what does this mean for maintenance and cost?

  The KD-575 is a reusable electronic instrument, meaning it is built for repeated use in clinical or home settings. This design reduces ongoing costs compared to disposable devices, though users must follow manufacturer guidelines for cleaning and maintenance to ensure accuracy and longevity.

• How does the KD-575’s regulatory clearance impact its use in healthcare facilities?

  The KD-575 holds FDA 510(k) clearance (K042418) under the Cardiovascular advisory committee, confirming it meets U.S. regulatory standards for non-invasive blood pressure monitors. This clearance allows healthcare providers to use it for clinical assessments, ensuring compliance with medical device regulations while assessing cardiovascular health.

• Does the KD-575 include any special features or limitations regarding storage or environmental conditions?

  The device data does not specify storage requirements or environmental limitations, so users should refer to the manufacturer’s instructions for proper handling. Since it is electronic and reusable, it may require protection from extreme temperatures, moisture, or physical damage to maintain functionality and accuracy.