Cleared Traditional

K850924 - JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K850924 · Vulcan Laboratories, Inc. · Anesthesiology device
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Jul 1985
Decision
136d
Days
Class 1
Risk

K850924 is an FDA 510(k) clearance for the JEE FRAME (VENTILATOR CIRCUIT SUPPORT). Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Vulcan Laboratories, Inc. (Birmingham, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vulcan Laboratories, Inc. devices

Submission Details

510(k) Number K850924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date July 19, 1985
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 139d · This submission: 136d
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.