Cleared Traditional

K981078 - TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 (FDA 510(k) Clearance)

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

K981078 · Transtracheal Systems · Anesthesiology device
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Jul 1998
Decision
121d
Days
Class 2
Risk

K981078 is an FDA 510(k) clearance for the TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000. 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 Transtracheal Systems (Boulder, US). The FDA issued a Cleared decision on July 23, 1998 after a review of 121 days - within the typical 510(k) review window.

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 Transtracheal Systems devices

Submission Details

510(k) Number K981078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1998
Decision Date July 23, 1998
Days to Decision 121 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
18d faster than avg
Panel avg: 139d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 284
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