Cleared Traditional

K021634 - KING LT

K021634 is an FDA 510(k) clearance for KING LT, manufactured by King Systems Corp.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K021634 · King Systems Corp. · Anesthesiology device
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Jan 2003
Decision
237d
Days
Class 1
Risk

K021634 is an FDA 510(k) clearance for the KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105. 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 January 9, 2003 after a review of 237 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. 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 King Systems Corp. devices

FDA 510(k) Submission Details - K021634

510(k) Number K021634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2002
Decision Date January 09, 2003
Days to Decision 237 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
97d slower than avg
Panel avg: 140d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

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 K021634.
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-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
K033186 · King Systems Corp. · Apr 2004
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