Cleared Traditional

K100040 - BIOHARNESS

K100040 is an FDA 510(k) clearance for BIOHARNESS, manufactured by Zephyr Technology Corporation. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K100040 · Zephyr Technology Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
330d
Days
Class 2
Risk

K100040 is an FDA 510(k) clearance for the BIOHARNESS. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Zephyr Technology Corporation (Annapolis, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K100040

510(k) Number K100040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2010
Decision Date December 03, 2010
Days to Decision 330 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 125d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 424
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