Product Code: CAE FDA class 1 21 CFR 868.5110

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

The Oropharyngeal Airway is an anesthesiology device inserted into the mouth and throat to maintain an open airway passage, preventing obstruction by the tongue or soft palate during sedation or unconsciousness. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification requirements. The product code is CAE, regulated under 21 CFR 868.5110, within the Anesthesiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

229

Registration Numbers

229

Unique Applicants

Years Active

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Basic Information

Product Code: CAE
Device Class: FDA class 1
Regulation Number: 868.5110
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130304	LMA FAMILY OF AIRWAYS	May 30, 2014	Substantially Equivalent	The Laryngeal Mask Co., Ltd.
K033189	KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305	May 04, 2004	Substantially Equivalent	King Systems Corp.
K033186	KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205	Apr 14, 2004	Substantially Equivalent	King Systems Corp.
K021634	KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105	Jan 09, 2003	Substantially Equivalent	King Systems Corp.
K955721	CUFFED OROPHARYNGEAL AIRWAY (COPA)	Mar 28, 1997	Substantially Equivalent	Mallinckrodt Medical
K960240	RUSCH OPTOSAFE	Apr 19, 1996	Substantially Equivalent	Rusch Intl.
K950613	KEISEI	Feb 14, 1996	Substantially Equivalent	Keisei (Usa) Co., Ltd.
K953400	GUEDEL AIRWAY	Oct 24, 1995	Substantially Equivalent	Mallinckrodt Medical
K933760	STB GUEDEL AIRWAY	Mar 23, 1994	Substantially Equivalent	Save-T-Breath Distributors C.C.
K936134	BERMAN AIRWAY	Jan 28, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K922748	GUEDEL AIRWAY	Jul 10, 1992	Substantially Equivalent	Oem Medical Div.
K913680	BERMAN INTUBATING/PHARYNGEAL AIRWAY	Oct 10, 1991	Substantially Equivalent	Chain Plastics Operations, Inc.
K904834	INTAVENT LARYNGEAL MASK	Jul 26, 1991	Substantially Equivalent	Intavent Intl. S.A.
K891926	KISS OF LIFE	Aug 21, 1989	Substantially Equivalent	Anthony Don Michael, M.D.
K892123	GOETTINGER EMERGENCY RESUSCITATION TUBE	Jul 14, 1989	Substantially Equivalent	Plastic Parts Corp.
K891586	ORAL AIRWAY	May 11, 1989	Substantially Equivalent	Dynarex Corp.
K892053	RESPAKIT	Apr 27, 1989	Substantially Equivalent	Protectical Health & Safety , Ltd.
K890566	BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES	Mar 15, 1989	Substantially Equivalent	Medi-Source, Inc.
K883593	#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY	Sep 30, 1988	Substantially Equivalent	Ecolab, Inc.
K881065	RESUS-AID	Jul 14, 1988	Substantially Equivalent	Applied Convergent Technologies, Inc.
K880241	'HILT-WAY' RESUSCITATOR	Mar 31, 1988	Substantially Equivalent	Medifield , Ltd.
K874412	THE PROTECTOR	Feb 12, 1988	Substantially Equivalent	Tri Jon, Inc.
K871403	MODIFIED C.P.R. MICROSHIELD	May 04, 1987	Substantially Equivalent	Westmark Enterprises, Inc.
K861482	RESUSIKIT	Jun 17, 1986	Substantially Equivalent	Begley Enterprises, Inc.
K862199	MEDTECH C.P.R. MASK	Jun 13, 1986	Substantially Equivalent	The Medtech Group, Inc.
K860949	DUAL-AID	May 06, 1986	Substantially Equivalent	Vitalograph , Ltd.
K861540	DISPOSABLE BERMAN AND GUEDEL AIRWAYS	May 02, 1986	Substantially Equivalent	Dryden Corp.
K861054	DISPOSABLE RESCUE BREATHING DEVICE	Apr 09, 1986	Substantially Equivalent	B & F Medical Products, Inc.
K860780	PLASTIC MOUTH BARRIER HCV-E	Apr 02, 1986	Substantially Equivalent	Westmark Enterprises, Inc.
K855137	CURITY FIBEROPTIC INTUBATING AIRWAY	Mar 11, 1986	Substantially Equivalent	The Kendal Co.
K854029	RESPIRATORY RESUSCITATION DEVICE	Mar 11, 1986	Substantially Equivalent	John H. Harrison
K850248	DISPOSABLE GUEDEL AIRWAY	Mar 12, 1985	Substantially Equivalent	Inmed Corp.
K844873	PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4	Feb 21, 1985	Substantially Equivalent	Pennine Medical , Ltd.
K842605	RESPIRONICS VENT EASY OXYGEN ENRICHME	Jul 27, 1984	Substantially Equivalent	Respironics, Inc.
K841429	MOUTH TO MASK EMERGENCY VENTILATION	Apr 17, 1984	Substantially Equivalent	O-Two Systems Intl., Inc.
K841120	RES-Q-MATE	Apr 05, 1984	Substantially Equivalent	Rsq Industries, Inc.
K832512	AIRWAY MASKS	Jan 17, 1984	Substantially Equivalent	Artec Environmental Monitoring Division
K833328	RESPIRONICS RESCUE DOME	Dec 16, 1983	Substantially Equivalent	Respironics, Inc.
K833482	WISDOM AIRWAY	Dec 05, 1983	Substantially Equivalent	Wisdom Corp.
K832435	BROOK LIFE SAVING AIRWAY DEVICE #900 &	Oct 04, 1983	Substantially Equivalent	La Societe Fianciere Senefin
K832471	ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III	Sep 12, 1983	Substantially Equivalent	Inmed Corp.
K831078	STRAITH ORAL AIRWAY	Jun 24, 1983	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K830767	WILLIAMS AIRWAY INTUBATOR	Mar 31, 1983	Substantially Equivalent	Williams Airway Intubator
K822727	RESCUER	Sep 28, 1982	Substantially Equivalent	Armstrong Ind., Inc.
K820709	AIRWAYS	Jun 25, 1982	Substantially Equivalent	Seven Harvest Intl. Import & Export
K821308	ESPREE' GUEDEL ESPREE BERMAN AIRWAY	May 21, 1982	Substantially Equivalent	Esp Plastics, Inc.
K820512	7CM BERMAN AIRWAY	Mar 26, 1982	Substantially Equivalent	Vital Signs, Inc.
K812822	RIND AIRWAY	Nov 16, 1981	Substantially Equivalent	Rind Medical Development
K810651	ORAL AIRWAYS	Mar 31, 1981	Substantially Equivalent	First Industries, Inc.
K810123	THE LUOMANEN ORAL AIRWAY	Feb 26, 1981	Substantially Equivalent	Luomanen Medical Products
K810099	AIRWAYS-OROPHARYNGEAL	Feb 05, 1981	Substantially Equivalent	American Hospital Supply Corp.
K810069	STERILE AIRWAY	Feb 02, 1981	Substantially Equivalent	Medspec Corp.
K800881	DISPOSABLE BERMAN AIRWAYS	May 08, 1980	Substantially Equivalent	Harvard Laboratories
K791799	CONPHAR AIRWAYS	Sep 19, 1979	Substantially Equivalent	Conphar, Inc.
K780601	AIRWAYS	May 19, 1978	Substantially Equivalent	Abco Dealers, Inc.
K770001	AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S	Jan 12, 1977	Substantially Equivalent	Omnicon Medical Corp.
K760488	AIRWAY, DUAL CHANNEL	Sep 03, 1976	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.