Cleared Traditional

K902967 - MICRO-EMED-SYSTEM

K902967 is an FDA 510(k) clearance for MICRO-EMED-SYSTEM, manufactured by Novel Electronics, Inc.. The device is a Class 1 Physical Medicine device with product code IKE cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K902967 · Novel Electronics, Inc. · Physical Medicine device
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Sep 1990
Decision
73d
Days
Class 1
Risk

K902967 is an FDA 510(k) clearance for the MICRO-EMED-SYSTEM. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Novel Electronics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1615 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Novel Electronics, Inc. devices

FDA 510(k) Submission Details - K902967

510(k) Number K902967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1990
Decision Date September 17, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

IKE Device Classification - Class 1, General Controls

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
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.