510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033186Substantially Equivalent

King Lt-D Disposable Oropharyngeal Airway, Models Klt 203, Klt 204 and Klt 205

King Systems Corporation., Noblesville IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033186 is the FDA 510(k) clearance record for KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205, a class I device, cleared for King Systems Corp. on under FDA product code CAE (Airway, Oropharyngeal, Anesthesiology). FDA records list 18 510(k) clearances for King Systems Corp., from to . As of , FDA records show 30 recalls naming K033186.

Clearance record

Decision date
Received
(196 days to decision)
Product code
CAE Airway, Oropharyngeal, Anesthesiology
Regulation
21 CFR 868.5110
Device class
Class I
Review panel
Anesthesiology
Applicant
King Systems Corp. 15011 Herriman Blvd., Noblesville IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAE

Trailing 12 months

FDA records hold no clearances under product code CAE in the trailing twelve months.

FDA records show no clearances under product code CAE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260