510(k) Report

FDA product code · General hospital

Cleaners, Medical Devices

MDZClass II21 CFR 880.6992510(k) required2 decisions since 19941 recall

2 FDA decisions since 1994. 1 recall names this code; it is not Class I.

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

FIG. A — Illustration, general hospital panel

Twenty years of MDZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — MDZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MDZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 880.6992.