510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822184Substantially Equivalent

ENT Metal Tongue Depressors

Kelleher Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822184 is the FDA 510(k) clearance record for ENT METAL TONGUE DEPRESSORS, a class I device, cleared for Kelleher Corp. on under FDA product code KBL (Depressor, Metal Tongue, Surgical). FDA records list 94 510(k) clearances for Kelleher Corp., from to . As of , FDA records show no recalls naming K822184.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KBL Depressor, Metal Tongue, Surgical
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kelleher Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KBL

Trailing 12 months

FDA records hold no clearances under product code KBL in the trailing twelve months.

FDA records show no clearances under product code KBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260