510(k) Report

510(k) · Cleared

Cleared

Decomat 228

K920406510(k) TraditionalCleared Apr 5, 1994795-day reviewClass II21 CFR 880.6992

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’s file for it is a 510(k) statement, which names no predicate.

Decided
Apr 5, 1994
Review
795 days
Class
Class II
Product code
MDZ
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K920406Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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

  • K920413Decomat a 8666Getinge International, Inc. · 19941 recall
  • K821842Gas Sterilization EquipmentGetinge International, Inc. · 1982
  • K821591Steam Sterilization EquipmentGetinge International, Inc. · 1982

Recent decisions in MDZ

The MDZ category page

  • K920413Decomat a 8666Getinge International, Inc. · 19941 recall

https://510kreport.com/device/K920406 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920406: Decomat 228.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920406

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026