Cleared Traditional

K971348 - FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (FDA 510(k) Clearance)

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

K971348 · Green Field Medical Sourcing, Inc. · Anesthesiology device
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Feb 1998
Decision
323d
Days
Class 2
Risk

K971348 is an FDA 510(k) clearance for the FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM. Classified as Airway, Esophageal (obturator) (product code CAO), Class II - Special Controls.

Submitted by Green Field Medical Sourcing, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Green Field Medical Sourcing, Inc. devices

Submission Details

510(k) Number K971348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date February 27, 1998
Days to Decision 323 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 139d · This submission: 323d
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.