Cleared Traditional

K962361 - TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND

K962361 is an FDA 510(k) clearance for TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND, manufactured by Laerdal Medical Corp.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K962361 · Laerdal Medical Corp. · Anesthesiology device
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Sep 1996
Decision
78d
Days
Class 1
Risk

K962361 is an FDA 510(k) clearance for the TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND. 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 September 5, 1996 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laerdal Medical Corp. devices

FDA 510(k) Submission Details - K962361

510(k) Number K962361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date September 05, 1996
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 17
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K962361.
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
K162729 · Cook Incorporated · Aug 2017
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
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MOLLOY INTUBATING STYLETTE
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RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
K955238 · Rusch Intl. · Feb 1996
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · Rusch, Inc. · Aug 1995
AIRGUIDE STYLETTE
K950713 · Polamedco, Inc. · May 1995