Cleared Traditional

K934462 - ADULT ANESTHESIA BREATHING CIRCUIT KITS

K934462 is the FDA 510(k) clearance for ADULT ANESTHESIA BREATHING CIRCUIT KITS by Zefon Medical Products. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K934462 · Zefon Medical Products · Anesthesiology device
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Mar 1994
Decision
169d
Days
Class 1
Risk

K934462 is an FDA 510(k) clearance for the ADULT ANESTHESIA BREATHING CIRCUIT KITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 169 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 K934462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 13, 1993
Decision Date March 01, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 140d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K934462.
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
PEDIATRIC GAS SAMPLING CIRCUITS
K932589 · Merit Medical Systems, Inc. · Jul 1993
ADULT GAS SAMPLING CIRCUITS
K932590 · Merit Medical Systems, Inc. · Jul 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932583 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932588 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · Merit Medical Systems, Inc. · Jul 1993