510(k) Report

510(k) · Cleared

Recalled · 2003

Decomat a 8666

K920413510(k) TraditionalCleared Apr 5, 1994795-day reviewClass II21 CFR 880.6992Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Getinge International, Inc. · MDZ Cleaners, Medical Devices

Cleared on Apr 5, 1994 after a 795-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided
Apr 5, 1994
Review
795 days
Class
Class II
Product code
MDZ
Recalls
1
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K920413Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2003Not classifiedZ-0908-03Device DesignHot water may splash from the washer chamber creating a burn hazard.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MDZ devices

MDZ Cleaners, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDZ

FDA has decided no MDZ device since 2007.

Median 510(k) review, days · MDZ

Too few MDZ 510(k)s in any year since 2007 to give a median.

Recalls per year · MDZ

No recall names MDZ since 2007.

Adverse event reports per year · MDZ

4in 2013

2009: 12012: 12013: 4
2007high 4 (2013) · low 0 (2007)2025

MAUDE reports naming product code MDZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—00
20120—01
20130—04
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Getinge International, Inc.

4 FDA decisions under this applicant name. See the company

  • K920406Decomat 228Getinge International, Inc. · 1994
  • K821842Gas Sterilization EquipmentGetinge International, Inc. · 1982
  • K821591Steam Sterilization EquipmentGetinge International, Inc. · 1982

Recent decisions in MDZ

The MDZ category page

  • K920406Decomat 228Getinge International, Inc. · 1994

https://510kreport.com/device/K920413 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920413: Decomat a 8666.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920413

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026