510(k) Report

FDA product code · Gastroenterology and urology

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

NTZClass II21 CFR 876.5820510(k) required1 decision since 20050 recalls

1 FDA decision since 2005. No recall names this code.

Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.

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 NTZ 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 · NTZ

FDA has decided no NTZ device since 2007.

Median 510(k) review, days · NTZ

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

Recalls per year · NTZ

No recall names NTZ since 2007.

Adverse event reports per year · NTZ

No MAUDE report names NTZ 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 — NTZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NTZ? 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

Which NTZ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K043031Serim Dialysate Monitor Test StripSerim Research Corp. · 20052generations

What has FDA decided in NTZ lately?

  • K043031Serim Dialysate Monitor Test StripSerim Research Corp. · 2005

The one NTZ decision →

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Other codes under 21 CFR 876.5820.

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