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
K904489Substantially Equivalent

Eureka Extension Cylinders

Eureka X-Ray Tube Corp., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904489 is the FDA 510(k) clearance record for EUREKA EXTENSION CYLINDERS, a class II device, cleared for Eureka X-Ray Tube Corp. on under FDA product code KPW (Device, Beam Limiting, X-Ray, Diagnostic). FDA records list 2 510(k) clearances for Eureka X-Ray Tube Corp., from to . As of , FDA records show no recalls naming K904489.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KPW Device, Beam Limiting, X-Ray, Diagnostic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Eureka X-Ray Tube Corp. 600 W. University Dr., Arlington Heights IL
Third party review
No

Clearances, product code KPW

Trailing 12 months

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

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