510(k) Report

FDA product code · Clinical chemistry

Instrument, Glucose, Noninvasive Technology

NCTClass IIIPMA required1 decision since 20010 recalls

1 FDA decision since 2001. 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, clinical chemistry panel

Twenty years of NCT 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 · NCT

FDA has decided no NCT device since 2007.

Median 510(k) review, days · NCT

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

Recalls per year · NCT

No recall names NCT since 2007.

Adverse event reports per year · NCT

3in 2024

2007: 12010: 12024: 3
2007high 3 (2024) · low 0 (2008)2025

MAUDE reports naming product code NCT, 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—01
20080—00
20090—00
20100—01
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—03
20250—00
20260—0—
FIG. 1 — NCT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NCT? 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