Cleared Traditional

K963376 - MICRO H2 (FDA 510(k) Clearance)

Class I Chemistry device.

K963376 · Micro Direct, Inc. · Chemistry device
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Jan 1997
Decision
150d
Days
Class 1
Risk

K963376 is an FDA 510(k) clearance for the MICRO H2. Classified as System, Breath Measurement (product code NRH), Class I - General Controls.

Submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1820 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Direct, Inc. devices

Submission Details

510(k) Number K963376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date January 24, 1997
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NRH System, Breath Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1820
Definition Breath Measurement Systems Are Used To Measure Constituents Of Exhaled Breath As An Aid In The Diagnosis Of Sugar/nutrient Malabsorbtion And Other Conditions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.