Cleared Special

K033186 - KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY

K033186 is an FDA 510(k) clearance for KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, manufactured by King Systems Corp.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Special 510(k) pathway after a 196-day FDA review.

K033186 · King Systems Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2004
Decision
196d
Days
Class 1
Risk

K033186 is an FDA 510(k) clearance for the KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on April 14, 2004 after a review of 196 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all King Systems Corp. devices

FDA 510(k) Submission Details - K033186

510(k) Number K033186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date April 14, 2004
Days to Decision 196 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 140d · This submission: 196d
Pathway characteristics
Modification to existing cleared device.

CAE Device Classification - Class 1, General Controls

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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 - CAE Airway, Oropharyngeal, Anesthesiology

All 18
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K033186.
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
K033189 · King Systems Corp. · May 2004
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634 · King Systems Corp. · Jan 2003
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · Mallinckrodt Medical · Mar 1997
RUSCH OPTOSAFE
K960240 · Rusch Intl. · Apr 1996
GUEDEL AIRWAY
K953400 · Mallinckrodt Medical · Oct 1995
BERMAN AIRWAY
K936134 · Smiths Industries Medical Systems, Inc. · Jan 1994