Cleared Traditional

K840326 - GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (FDA 510(k) Clearance)

Class I Anesthesiology device.

K840326 · Siemens Elema AB · Anesthesiology device
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Jun 1984
Decision
134d
Days
Class 1
Risk

K840326 is an FDA 510(k) clearance for the GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB. Classified as Yoke Assembly, Medical Gas (product code CAM), Class I - General Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6885 - 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 Siemens Elema AB devices

Submission Details

510(k) Number K840326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date June 07, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 139d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAM Yoke Assembly, Medical Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6885
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.