Cleared Traditional

K950713 - AIRGUIDE STYLETTE

K950713 is an FDA 510(k) clearance for AIRGUIDE STYLETTE, manufactured by Polamedco, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K950713 · Polamedco, Inc. · Anesthesiology device
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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

FDA 510(k) Submission Details - K950713

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

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.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 14
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K950713.
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