Cleared Traditional

K864200 - VETA/VENTED ESOPHAGEAL TUBE AIRWAY (FDA 510(k) Clearance)

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

K864200 · Cranco Co. · Anesthesiology device
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Mar 1987
Decision
141d
Days
Class 2
Risk

K864200 is an FDA 510(k) clearance for the VETA/VENTED ESOPHAGEAL TUBE AIRWAY. Classified as Airway, Esophageal (obturator) (product code CAO), Class II - Special Controls.

Submitted by Cranco Co. (Salt Lake City, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5650 - 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 Cranco Co. devices

Submission Details

510(k) Number K864200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date March 17, 1987
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 139d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAO Airway, Esophageal (obturator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5650
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.