510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812405Substantially Equivalent

Sterile Tv Camera & Cord Cover

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

K812405 is the FDA 510(k) clearance record for STERILE TV CAMERA & CORD COVER, a class I device, cleared for Hydro-Med Products, Inc. on under FDA product code KQM (Camera, Surgical And Accessories). FDA records list 13 510(k) clearances for Hydro-Med Products, Inc., from to . As of , FDA records show no recalls naming K812405.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KQM Camera, Surgical And Accessories
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Hydro-Med Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQM

Trailing 12 months

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

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