Cleared Traditional

K874450 - SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT (FDA 510(k) Clearance)

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

K874450 · Surgitech C/O Collier, Shannon, Rill & Scott · Anesthesiology device
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Feb 1988
Decision
123d
Days
Class 2
Risk

K874450 is an FDA 510(k) clearance for the SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Surgitech C/O Collier, Shannon, Rill & Scott (Washington, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 123 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 Surgitech C/O Collier, Shannon, Rill & Scott devices

Submission Details

510(k) Number K874450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1987
Decision Date February 29, 1988
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 139d · This submission: 123d
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.