Cleared Traditional

K850309 - COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K850309 · Ackrad Laboratories · Anesthesiology device
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Feb 1985
Decision
20d
Days
Class 1
Risk

K850309 is an FDA 510(k) clearance for the COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK. Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5280 - the FDA anesthesiology and respiratory 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 Ackrad Laboratories devices

Submission Details

510(k) Number K850309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1985
Decision Date February 14, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 139d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JAY Support, Breathing Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5280
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.