Cleared Traditional

K982943 - TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982943 · Transtracheal Systems · Anesthesiology device
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Jul 1999
Decision
325d
Days
Class 2
Risk

K982943 is an FDA 510(k) clearance for the TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Transtracheal Systems (Boulder, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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. Elevated predicate reliance profile. 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 Transtracheal Systems devices

Submission Details

510(k) Number K982943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date July 12, 1999
Days to Decision 325 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
186d slower than avg
Panel avg: 139d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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.