Cleared Traditional

K930957 - ZEFON GAS SAMPLING LINES

K930957 is the FDA 510(k) clearance for ZEFON GAS SAMPLING LINES by Zefon Medical Products. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K930957 · Zefon Medical Products · Anesthesiology device
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Jul 1993
Decision
129d
Days
Class 2
Risk

K930957 is an FDA 510(k) clearance for the ZEFON GAS SAMPLING LINES. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 K930957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 23, 1993
Decision Date July 02, 1993
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 80
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