Holter Screening Monitor HS-221

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

510(k) Number

K842462 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Advantage Medical Systems, Inc. →

• What is the Holter Screening Monitor HS-221 used for?

  The Holter Screening Monitor HS-221 is a cardiac monitor that includes cardiotachometer and rate alarm functions, designed to monitor cardiac rhythm and detect abnormal heart rates by measuring and analyzing electrical activity of the heart over time.

• How is the Holter Screening Monitor HS-221 supplied and is it reusable?

  The device is supplied as a complete cardiac monitoring system by Advantage Medical Systems, Inc., and based on its classification as a Class II monitor under FDA regulation 870.2300, it is intended for repeated use with appropriate maintenance and calibration, not as a single-use device.

• What regulatory pathway was used for the Holter Screening Monitor HS-221?

  The Holter Screening Monitor HS-221 received FDA 510(k) clearance through a traditional review process under submission K842462, demonstrating substantial equivalence to a legally marketed predicate device for cardiac monitoring with cardiotachometer and rate alarm functions.