Cleared Traditional

K954771 - TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K954771 · Laerdal Medical Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
205d
Days
Class 1
Risk

K954771 is an FDA 510(k) clearance for the TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & .... Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Laerdal Medical Corp. (Wappingers Falls, US). The FDA issued a Cleared decision on May 9, 1996 after a review of 205 days - an extended review cycle.

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 Laerdal Medical Corp. devices

Submission Details

510(k) Number K954771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date May 09, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 139d · This submission: 205d
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.