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
K790995Substantially Equivalent

Contex

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

K790995 is the FDA 510(k) clearance record for CONTEX, a class I device, cleared for Foam Tek, Inc. on under FDA product code FMP (Protector, Skin Pressure). FDA records list one 510(k) clearance for Foam Tek, Inc. As of , FDA records show no recalls naming K790995.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FMP Protector, Skin Pressure
Regulation
21 CFR 880.6450
Device class
Class I
Review panel
General Hospital
Applicant
Foam Tek, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FMP

Trailing 12 months

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

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