Cleared Traditional

K950713 - AIRGUIDE STYLETTE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K950713 · Polamedco, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
91d
Days
Class 1
Risk

K950713 is an FDA 510(k) clearance for the AIRGUIDE STYLETTE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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 Polamedco, Inc. devices

Submission Details

510(k) Number K950713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date May 17, 1995
Days to Decision 91 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
48d faster than avg
Panel avg: 139d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.