CAE · Class I · 21 CFR 868.5110

FDA Product Code CAE: Airway, Oropharyngeal, Anesthesiology

Leading manufacturers include King Systems Corp., Mallinckrodt Medical and Inmed Corp..

57
Total
57
Cleared
88d
Avg days
1976
Since

FDA 510(k) Cleared Airway, Oropharyngeal, Anesthesiology Devices (Product Code CAE)

57 devices
1–24 of 57
Cleared May 30, 2014
LMA FAMILY OF AIRWAYS
K130304
The Laryngeal Mask Co., Ltd.
Anesthesiology · 477d
Cleared May 04, 2004
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
K033189
King Systems Corp.
Anesthesiology · 216d
Cleared Apr 14, 2004
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
K033186
King Systems Corp.
Anesthesiology · 196d
Cleared Jan 09, 2003
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634
King Systems Corp.
Anesthesiology · 237d
Cleared Mar 28, 1997
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721
Mallinckrodt Medical
Anesthesiology · 466d
Cleared Apr 19, 1996
RUSCH OPTOSAFE
K960240
Rusch Intl.
Anesthesiology · 94d
Cleared Feb 14, 1996
KEISEI
K950613
Keisei (Usa) Co., Ltd.
Anesthesiology · 369d
Cleared Oct 24, 1995
GUEDEL AIRWAY
K953400
Mallinckrodt Medical
Anesthesiology · 96d
Cleared Jan 28, 1994
BERMAN AIRWAY
K936134
Smiths Industries Medical Systems, Inc.
Anesthesiology · 36d
Cleared May 11, 1989
ORAL AIRWAY
K891586
Dynarex Corp.
Anesthesiology · 52d
Cleared May 06, 1986
DUAL-AID
K860949
Vitalograph , Ltd.
Anesthesiology · 55d
Cleared May 02, 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540
Dryden Corp.
Anesthesiology · 8d
Cleared Apr 09, 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054
B & F Medical Products, Inc.
Anesthesiology · 21d
Cleared Mar 11, 1986
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137
The Kendal Co.
Anesthesiology · 78d
Cleared Mar 12, 1985
DISPOSABLE GUEDEL AIRWAY
K850248
Inmed Corp.
Anesthesiology · 49d
Cleared Jul 27, 1984
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605
Respironics, Inc.
Anesthesiology · 22d
Cleared Dec 16, 1983
RESPIRONICS RESCUE DOME
K833328
Respironics, Inc.
Anesthesiology · 80d
Cleared Sep 12, 1983
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III
K832471
Inmed Corp.
Anesthesiology · 48d
Cleared Mar 26, 1982
7CM BERMAN AIRWAY
K820512
Vital Signs, Inc.
Anesthesiology · 29d
Cleared Feb 05, 1981
AIRWAYS-OROPHARYNGEAL
K810099
American Hospital Supply Corp.
Anesthesiology · 22d
Cleared Sep 19, 1979
CONPHAR AIRWAYS
K791799
Conphar, Inc.
Anesthesiology · 6d
Cleared May 19, 1978
AIRWAYS
K780601
Abco Dealers, Inc.
Anesthesiology · 39d
Cleared Sep 03, 1976
AIRWAY, DUAL CHANNEL
K760488
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 14d

About Product Code CAE - Regulatory Context