510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920413Substantially Equivalent

Decomat a 8666

Getinge International, Inc., Lakewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920413 is the FDA 510(k) clearance record for DECOMAT A 8666, a class II device, cleared for Getinge International, Inc. on under FDA product code MDZ (Cleaners, Medical Devices). FDA records list 4 510(k) clearances for Getinge International, Inc., from to . As of , FDA records show one recall naming K920413.

Clearance record

Decision date
Received
(795 days to decision)
Product code
MDZ Cleaners, Medical Devices
Regulation
21 CFR 880.6992
Device class
Class II
Review panel
General Hospital
Applicant
Getinge International, Inc. 1100 Towbin Ave., Lakewood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MDZ

Trailing 12 months

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

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