HyperQ System Modification

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

Full name

Modification to Hyperq System

510(k) Number

K072389 ↗

FDA Product Code

MWI

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Hyperq Ad-100 System

  Class II

  FDA 510(k) K102579 Active Cleared 2 Dec 2010

• Hyperq System

  Class II

  FDA 510(k) K042981 Active Cleared 10 Mar 2005

• Hyperq System

  Class II

  FDA 510(k) K070624 Active Cleared 6 Apr 2007

• Hyperq System

  Class II

  FDA 510(k) K082564 Active Cleared 20 Oct 2008

• What clinical setting is the HyperQ System Modification designed for, and how does it differ from standard ECG monitoring?

  The HyperQ System Modification is specifically intended for use in cardiovascular testing facilities, such as those performing stress tests like treadmill or bicycle ergometry. Unlike standard ECG monitors, it focuses on analyzing high-frequency components of the QRS complex, which may provide additional insights during dynamic stress testing. It remains classified as a physiological monitor without arrhythmia detection or alarms, so its primary purpose is data measurement, processing, and display—not diagnostic alarms.

• Is the HyperQ System Modification a standalone device, or is it an upgrade to an existing system, and how is it supplied?

  The HyperQ System Modification is not a standalone device but rather an upgrade to the original HyperQ System. It is supplied as a modification kit or software/hardware update to enhance the system’s ability to measure and analyze high-frequency ECG data during stress testing. The exact supply format (e.g., physical components, software download) isn’t detailed, but it aligns with the original system’s use in clinical settings.

• How is the device’s regulatory status defined, and what does the ‘Substantially Equivalent’ determination mean for buyers?

  The HyperQ System Modification was cleared via an FDA 510(k) Special Review (K072389) with a ‘Substantially Equivalent’ (SESE) determination under product code MWI. This means the FDA found the modification to be as safe and effective as a legally marketed predicate device (the original HyperQ System) for its intended use—here, high-frequency QRS analysis during stress testing. Buyers can rely on this determination for compliance with U.S. regulatory requirements.

• Does the device have any specific sterility or reuse requirements, and how should it be handled in a clinical environment?

  The provided data does not explicitly state whether the HyperQ System Modification is sterile or designated for single-use/reuse. However, as a physiological monitor used in clinical settings, it should follow standard ECG monitoring protocols for hygiene and maintenance. If reusable, it would require cleaning and disinfection per facility protocols; if single-use, it would follow typical disposable medical device handling. Always consult the manufacturer’s instructions for specific guidance.

• What types of stress tests is the HyperQ System Modification compatible with, and what data does it prioritize?

  The modification is designed for use with treadmill or bicycle ergometry stress tests, where it measures and analyzes electrocardiogram (ECG) data with a focus on high-frequency components of the QRS complex. This specialized analysis may help clinicians assess cardiac responses during dynamic exertion, though it does not include arrhythmia detection or alarms. Its output is intended for diagnostic interpretation by qualified healthcare providers.