510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950566Substantially Equivalent

Decomat 4656

Getinge Disinfection AB, Toms River NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950566 is the FDA 510(k) clearance record for DECOMAT 4656, a class II device, cleared for Getinge Disinfection, Inc. on under FDA product code LDS (Device, Pasteurization, Hot Water). FDA records list one 510(k) clearance for Getinge Disinfection, Inc. As of , FDA records show no recalls naming K950566.

Clearance record

Decision date
Received
(253 days to decision)
Product code
LDS Device, Pasteurization, Hot Water
Regulation
21 CFR 880.6991
Device class
Class II
Review panel
General Hospital
Applicant
Getinge Disinfection, Inc. 1415 Hooper Ave., Toms River NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LDS

Trailing 12 months

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

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