Cleared Traditional

K942082 - MODEL 6323 OXYGEN CONCENTRATOR

K942082 is an FDA 510(k) clearance for MODEL 6323 OXYGEN CONCENTRATOR, manufactured by Dynotec Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K942082 · Dynotec Corp. · Anesthesiology device
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Dec 1994
Decision
223d
Days
Class 2
Risk

K942082 is an FDA 510(k) clearance for the MODEL 6323 OXYGEN CONCENTRATOR. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Dynotec Corp. (San Diego, US). The FDA issued a Cleared decision on December 8, 1994 after a review of 223 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Dynotec Corp. devices

FDA 510(k) Submission Details - K942082

510(k) Number K942082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date December 08, 1994
Days to Decision 223 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
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 215
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K942082.
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