Cleared Traditional

K972385 - FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (FDA 510(k) Clearance)

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

K972385 · Smiths Industries Medical Systems, Inc. · Anesthesiology device
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Jan 1998
Decision
208d
Days
Class 2
Risk

K972385 is an FDA 510(k) clearance for the FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 208 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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.

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Submission Details

510(k) Number K972385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date January 20, 1998
Days to Decision 208 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 139d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - JOH Tube Tracheostomy And Tube Cuff

All 108
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