510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923099Substantially Equivalent

X-Ray Drapes

Hydro-Med Products, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923099 is the FDA 510(k) clearance record for X-RAY DRAPES, a class I device, cleared for Hydro-Med Products, Inc. on under FDA product code IWQ (Curtain, Protective, Radiographic). FDA records list 13 510(k) clearances for Hydro-Med Products, Inc., from to . As of , FDA records show no recalls naming K923099.

Clearance record

Decision date
Received
(112 days to decision)
Product code
IWQ Curtain, Protective, Radiographic
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Hydro-Med Products, Inc. P.O. Box 540905, Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code IWQ

Trailing 12 months

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

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