KBHClass I

Adenotome

21 CFR 874.4420 / Ear, Nose, Throat

KBH is the FDA product code for Adenotome, a class I device type, regulated under 21 CFR 874.4420. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1982-08-25, and no recalls.

Classification record

Product code: KBH
Device name: Adenotome
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: 1
Ingested recalls: 0

Clearances, product code KBH

By decision year

1 clearance under product code KBH with a decision year between 1982 and 1982, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KBH by decision year
Year	Clearances
1982	1

Applicants with the most clearances

Product code KBH

Applicants holding the most 510(k) clearances under product code KBH
Applicant	Clearances
Kelleher Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order

Recent clearances

Product code KBH

K822262Class IAdenotomesKelleher Corp. / cleared 1982-08-25

Recent recalls

Product code KBH

FDA records show no recalls under product code KBH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)