KAEClass I

Forceps, Ent

21 CFR 874.4420 / Ear, Nose, Throat

KAE is the FDA product code for Forceps, Ent, a class I device type, regulated under 21 CFR 874.4420. As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 1986-02-14, and one recall.

Classification record

Product code: KAE
Device name: Forceps, Ent
Regulation: 21 CFR 874.4420
Device class: Class I
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 14
Ingested recalls: 1

Clearances, product code KAE

By decision year

14 clearances under product code KAE with a decision year between 1978 and 1986, 1978 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code KAE by decision year
Year	Clearances
1978	4
1981	1
1982	2
1984	3
1985	3
1986	1

Applicants with the most clearances

Product code KAE

Applicants holding the most 510(k) clearances under product code KAE
Applicant	Clearances
Edward Weck, Inc.	4
Artiberia	3
Microtek Medical LLC	3
Treace Medical, Inc.	2
American V. Mueller	1
Downs Surgical, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 217 companies shown, in name order