Cleared Traditional

K801379 - CUFFED TRACHEA TUBE FOR USE W/PERTRACH

K801379 is the FDA 510(k) clearance for CUFFED TRACHEA TUBE FOR USE W/PERTRACH by Frederic J. Toye, M.D.. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K801379 · Frederic J. Toye, M.D. · Anesthesiology device
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Sep 1980
Decision
90d
Days
Class 2
Risk

K801379 is an FDA 510(k) clearance for the CUFFED TRACHEA TUBE FOR USE W/PERTRACH. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Frederic J. Toye, M.D. (Walker, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 90 days - within the typical 510(k) review window.

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.

View all Frederic J. Toye, M.D. devices

Submission Details

510(k) Number K801379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1980
Decision Date September 09, 1980
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 24
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K801379.
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · Shiley, Inc. · Feb 1981
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
K791044 · Extracorporeal Medical Specialities, Inc. · Jun 1979
TRACH CARE KIT
K790437 · Abco Dealers, Inc. · Apr 1979
ENDOTRACHEAL TUBE
K772138 · Medline Industries, Inc. · Dec 1977