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BioHarness

by Zephyr Technology Corporation 510(k)

Active United States

510(k) K100040

Overview

This device is a physiological monitor with arrhythmia detection or alarms, classified as a Class II medical device under the Cardiovascular medical specialty. It is identified by the product code MHX and regulation number 870.1025.

The BioHarness received FDA 510(k) clearance (K100040) on December 3, 2010, as substantially equivalent to a predicate device. It is manufactured by Zephyr Technology Corporation in Annapolis, Maryland, and is intended for use in monitoring patient physiological parameters.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100040 Date3 Dec 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Zephyr Technology Corporation

Questions

  • What is the BioHarness used for?

    The BioHarness is a physiological monitor designed to detect arrhythmias and provide alarms, intended for monitoring patient physiological parameters in cardiovascular care settings.

  • How is the BioHarness supplied and is it reusable?

    The BioHarness is a reusable physiological monitor manufactured by Zephyr Technology Corporation; it is not a single-use device and is intended for repeated clinical use after proper cleaning and maintenance.

  • What regulatory pathway was used for the BioHarness clearance?

    The BioHarness received FDA 510(k) clearance under K100040 on December 3, 2010, as substantially equivalent to a predicate device, following a traditional review process.