510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822618Substantially Equivalent

Emergency Tracheostomy Instrument Set

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

K822618 is the FDA 510(k) clearance record for EMERGENCY TRACHEOSTOMY INSTRUMENT SET, a class I device, cleared for Kelleher Corp. on under FDA product code LJW (Tracheotome). FDA records list 94 510(k) clearances for Kelleher Corp., from to . As of , FDA records show no recalls naming K822618.

Clearance record

Decision date
Received
(148 days to decision)
Product code
LJW Tracheotome
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kelleher Corp. 1301 School St., Richmond VA
Third party review
No

Clearances, product code LJW

Trailing 12 months

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

FDA records show no clearances under product code LJW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJW, 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