CAE — Airway, Oropharyngeal, Anesthesiology Class I

FDA Device Classification

Classification Details

Product Code
CAE
Device Class
Class I
Regulation Number
868.5110
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130304laryngeal mask coLMA FAMILY OF AIRWAYSMay 30, 2014
K033189king systemsKING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30May 4, 2004
K033186king systemsKING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205April 14, 2004
K021634king systemsKING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105January 9, 2003
K955721mallinckrodt medicalCUFFED OROPHARYNGEAL AIRWAY (COPA)March 28, 1997
K960240rusch intlRUSCH OPTOSAFEApril 19, 1996
K950613keisei (usa) coKEISEIFebruary 14, 1996
K953400mallinckrodt medicalGUEDEL AIRWAYOctober 24, 1995
K933760save-t-breath distributors c.cSTB GUEDEL AIRWAYMarch 23, 1994
K936134smiths industries medical systemsBERMAN AIRWAYJanuary 28, 1994
K922748oem medical divGUEDEL AIRWAYJuly 10, 1992
K913680chain plastics operationsBERMAN INTUBATING/PHARYNGEAL AIRWAYOctober 10, 1991
K904834intavent intlINTAVENT LARYNGEAL MASKJuly 26, 1991
K891926anthony don michael, m.dKISS OF LIFEAugust 21, 1989
K892123plastic partsGOETTINGER EMERGENCY RESUSCITATION TUBEJuly 14, 1989
K891586dynarexORAL AIRWAYMay 11, 1989
K892053protectical health and safetyRESPAKITApril 27, 1989
K890566medi-sourceBERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZESMarch 15, 1989
K883593ecolab#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAYSeptember 30, 1988
K881065applied convergent technologiesRESUS-AIDJuly 14, 1988