Cleared Traditional

K840326 - GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB

K840326 is an FDA 510(k) clearance for GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB, manufactured by Siemens Elema AB. The device is a Class 1 Anesthesiology device with product code CAM cleared through the Traditional 510(k) pathway after a 134-day FDA review.

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

FDA 510(k) Submission Details - K840326

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

CAM Device Classification - Class 1, General Controls

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.