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Decomat A 8666

by Getinge International, Inc.

510(k) K920413

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920413 Date5 Apr 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0908-03 FDA Unclassified (pre-2012) initiated 25 Mar 2003 on shared 510(k) K920413

    Hot water may splash from the washer chamber creating a burn hazard.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MDZ
Device Class
Class II
Regulation
21 CFR Part 880.6992
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Decomat A 8666 is a fully automatic washer-disinfector designed for the cleaning and disinfecting of contaminated dishware. It is intended for use in hospital, laboratory, and pharmaceutical industry settings.

This device is regulated under FDA 510(k) clearance K920413. It is classified as a medical device cleaner under regulation number 880.6992.

Other devices from Getinge International, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Decomat A 8666?

    The Decomat A 8666 is a fully automatic washer-disinfector engineered specifically for the cleaning and disinfection of contaminated dishware. It is designed to support hygiene requirements in hospital, laboratory, and pharmaceutical industry environments.

  • In what types of facilities is this device intended to be used?

    This device is intended for use in professional settings where specialized cleaning of dishware is required, specifically within hospital departments, research laboratories, and the pharmaceutical industry.

  • What is the regulatory status of the Decomat A 8666?

    The Decomat A 8666 is regulated under FDA 510(k) clearance number K920413. It is classified as a medical device cleaner under regulation number 880.6992, falling under the General Hospital medical specialty.