Cleared Traditional

K940220 - REBREATHER BAGS

K940220 is an FDA 510(k) clearance for REBREATHER BAGS, manufactured by Zefon Medical Products. The device is a Class 1 Anesthesiology device with product code BTC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K940220 · Zefon Medical Products · Anesthesiology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K940220

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
14d faster than avg
Panel avg: 140d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

BTC Device Classification - Class 1, General Controls

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.

Regulatory Peers - BTC Bag, Reservoir

All 10
Devices cleared under the same product code (BTC) and FDA review panel - the closest regulatory comparables to K940220.
PeDIA
K181424 · Pedia, LLC · Sep 2018
PRECISION MED PRODUCTS, LTD. BREATHING BAGS
K932496 · Precision Med Products, Ltd. · Jul 1993
BREATHING BAGS
K932581 · Med-Plastics Intl., Inc. · Jul 1993
BREATHING BAGS
K932584 · Merit Medical Systems, Inc. · Jul 1993
BREATHING BAGS
K932191 · Life Shield Healthcare Products, Inc. · Jul 1993
KING SYSTEMS, BREATHING BAG
K880680 · King Systems Corp. · Mar 1988