CAIClass I

Circuit, Breathing (W Connector, Adaptor, Y Piece)

21 CFR 868.5240 / Anesthesiology

CAI is the FDA product code for Circuit, Breathing (W Connector, Adaptor, Y Piece), a class I device type, regulated under 21 CFR 868.5240. As of 2026-09-10, FDA records hold 184 510(k) clearances under this code, the most recent dated 1995-12-29, and 204 recalls.

Classification record

Product code: CAI
Device name: Circuit, Breathing (W Connector, Adaptor, Y Piece)
Regulation: 21 CFR 868.5240
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: 184
Ingested recalls: 205

Clearances, product code CAI

By decision year

184 clearances under product code CAI with a decision year between 1976 and 1995, 1993 the highest year at 47.

Show the numbers

510(k) clearances under FDA product code CAI by decision year
Year	Clearances
1976	3
1977	8
1978	2
1979	3
1980	4
1981	5
1982	7
1983	8
1984	9
1985	15
1986	5
1987	5
1988	3
1989	4
1990	5
1991	10
1992	1
1993	47
1994	29
1995	11

Applicants with the most clearances

Product code CAI

Applicants holding the most 510(k) clearances under product code CAI
Applicant	Clearances
Mag, Inc.	15
Sigma Medical, Inc.	13
Life Shield Healthcare Products, Inc.	10
Precision Med Products, Ltd.	10
Med-Plastics Intl., Inc.	9
Merit Medical Systems, Inc.	9
Prima, Inc.	8
Vital Signs, Inc.	5
Airlife, Inc.	4
Bird Life Design	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 181 companies shown, in name order