Cleared Special

K033186 - KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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 24
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K033186.
LMA FAMILY OF AIRWAYS
K130304 · The Laryngeal Mask Co., Ltd. · May 2014
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
KEISEI
K950613 · Keisei (Usa) Co., Ltd. · Feb 1996
K033186 · KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
Download PDF FDA Summary King Systems Corp.