Cleared Traditional

K760998 - ENDOTRACHAEL TUBE AND HOLDER

K760998 is the FDA 510(k) clearance for ENDOTRACHAEL TUBE AND HOLDER by Mcgaw Respiratory Therapy. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K760998 · Mcgaw Respiratory Therapy · Anesthesiology device
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Nov 1976
Decision
11d
Days
Class 2
Risk

K760998 is an FDA 510(k) clearance for the ENDOTRACHAEL TUBE AND HOLDER. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mcgaw Respiratory Therapy (Mchenry, US). The FDA issued a Cleared decision on November 19, 1976 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mcgaw Respiratory Therapy devices

Submission Details

510(k) Number K760998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1976
Decision Date November 19, 1976
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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.