Cleared Traditional

K971348 - FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM

K971348 is an FDA 510(k) clearance for FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGE..., manufactured by Green Field Medical Sourcing, Inc.. The device is a Class 2 Anesthesiology device with product code CAO cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K971348 · Green Field Medical Sourcing, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971348

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 140d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAO Device Classification - Class 2, Special Controls

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.