Cleared Traditional

K100040 - BIOHARNESS (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100040 · Zephyr Technology Corporation · Cardiovascular device
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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.

View all Zephyr Technology Corporation devices

Submission Details

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
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.

Device Classification

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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