510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891152Substantially Equivalent

Grand Cooling Machine

KCI USA, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891152 is the FDA 510(k) clearance record for GRAND COOLING MACHINE, a class II device, cleared for Kinetic Concepts, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 76 510(k) clearances for KCI USA, INC., from to . As of , FDA records show no recalls naming K891152.

Clearance record

Decision date
Received
(20 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Kinetic Concepts, Inc. P.O. Box 8588, San Antonio TX
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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