CAEClass I

Airway, Oropharyngeal, Anesthesiology

21 CFR 868.5110 / Anesthesiology

CAE is the FDA product code for Airway, Oropharyngeal, Anesthesiology, a class I device type, regulated under 21 CFR 868.5110. As of 2026-09-10, FDA records hold 57 510(k) clearances under this code, the most recent dated 2014-05-30, and 76 recalls.

Classification record

Product code: CAE
Device name: Airway, Oropharyngeal, Anesthesiology
Regulation: 21 CFR 868.5110
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 57
Ingested recalls: 76

Clearances, product code CAE

By decision year

57 clearances under product code CAE with a decision year between 1976 and 2014, 1986 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code CAE by decision year
Year	Clearances
1976	1
1977	1
1978	1
1979	1
1980	1
1981	5
1982	4
1983	6
1984	4
1985	2
1986	8
1987	1
1988	4
1989	5
1991	2
1992	1
1994	2
1995	1
1996	2
1997	1
2003	1
2004	2
2014	1

Applicants with the most clearances

Product code CAE

Applicants holding the most 510(k) clearances under product code CAE
Applicant	Clearances
King Systems Corporation.	3
Mallinckrodt Medical	2
Respironics, Inc.	2
Westmark Enterprises, Inc.	2
Abco Dealers, Inc.	1
American Hospital Supply	1
Anthony Don Michael, M.D.	1
Applied Convergent Technologies, Inc.	1
Armstrong Ind., Inc.	1
Artec Environmental Monitoring Division	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 222 companies shown, in name order