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
K800134Substantially Equivalent

Hope Model 126, Auto/proces., Den. Flm

Hope Industries, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800134 is the FDA 510(k) clearance record for HOPE MODEL 126, AUTO/PROCES., DEN. FLM, a class I device, cleared for Hope Industries, Inc. on under FDA product code IWZ (Film, Radiographic). FDA records list one 510(k) clearance for Hope Industries, Inc. As of , FDA records show no recalls naming K800134.

Clearance record

Decision date
Received
(102 days to decision)
Product code
IWZ Film, Radiographic
Regulation
21 CFR 892.1840
Device class
Class I
Review panel
Radiology
Applicant
Hope Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWZ

Trailing 12 months

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

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