510(k) Report

FDA product code · Gastroenterology and urology

Strip, Test, Reagent, Residuals For Dialysate

MSZClass II21 CFR 876.5665510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

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, gastroenterology and urology panel

Twenty years of MSZ 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 · MSZ

FDA has decided no MSZ device since 2007.

Median 510(k) review, days · MSZ

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

Recalls per year · MSZ

No recall names MSZ since 2007.

Adverse event reports per year · MSZ

No MAUDE report names MSZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
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 — MSZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MSZ? 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 876.5665.

NIH Disinfectant, Subsystem, Water PurificationMSY Strip, Test, Reagent, Residuals For Dialysate…NHV System, Water Purification, General Medical UseFIP Subsystem, Water PurificationPSX Chlorine Meter