Cleared Traditional

K940220 - REBREATHER BAGS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K940220 · Zefon Medical Products · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
126d
Days
Class 1
Risk

K940220 is an FDA 510(k) clearance for the REBREATHER BAGS. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - 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 Zefon Medical Products devices

Submission Details

510(k) Number K940220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date May 27, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 139d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
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.