Cleared Traditional

RIVER MEDICAL MICRODRILL SYSTEM (K905437) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K905437 · River Medical, Inc. · Ear, Nose, Throat device
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May 1991
Decision
177d
Days
Class 1
Risk

K905437 is an FDA 510(k) clearance for the RIVER MEDICAL MICRODRILL SYSTEM. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by River Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 177 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all River Medical, Inc. devices

Submission Details

510(k) Number K905437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date May 30, 1991
Days to Decision 177 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 89d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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.