Cleared Traditional

K903939 - PANDA HELIUM GAS ANALYZER

K903939 is an FDA 510(k) clearance for PANDA HELIUM GAS ANALYZER, manufactured by Medical Associated Services, Inc.. The device is a Class 2 Anesthesiology device with product code BSE cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K903939 · Medical Associated Services, Inc. · Anesthesiology device
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Jan 1991
Decision
129d
Days
Class 2
Risk

K903939 is an FDA 510(k) clearance for the PANDA HELIUM GAS ANALYZER. Classified as Analyzer, Gas, Helium, Gaseous-phase (product code BSE), Class II - Special Controls.

Submitted by Medical Associated Services, Inc. (Hatfield, US). The FDA issued a Cleared decision on January 3, 1991 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 868.1640 - 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.

FDA 510(k) Submission Details - K903939

510(k) Number K903939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1990
Decision Date January 03, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
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.

BSE Device Classification - Class 2, Special Controls

Product Code BSE Analyzer, Gas, Helium, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1640
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.