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
K892659Substantially Equivalent

Electrodelca

Oldelft Corp. of America, Fairfax VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892659 is the FDA 510(k) clearance record for ELECTRODELCA, a class II device, cleared for Oldelft Corp. of America on under FDA product code IZG (System, X-Ray, Photofluorographic). FDA records list 9 510(k) clearances for Oldelft Corp. of America, from to . As of , FDA records show no recalls naming K892659.

Clearance record

Decision date
Received
(222 days to decision)
Product code
IZG System, X-Ray, Photofluorographic
Regulation
21 CFR 892.1730
Device class
Class II
Review panel
Radiology
Applicant
Oldelft Corp. of America 2735 Dorr Ave., Fairfax VA
Third party review
No

Clearances, product code IZG

Trailing 12 months

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

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