510(k) Report

FDA product code · Clinical chemistry

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

QIIClass II21 CFR 862.1355510(k) required1 decision since 20190 recalls

1 FDA decision since 2019. No recall names this code. The most-cited predicate is K191833, named by 1 later device.

An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate…

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 QII 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 · QII

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QII

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

Recalls per year · QII

No recall names QII since 2007.

Adverse event reports per year · QII

2in 2025

2020: 22021: 932022: 592023: 622024: 182025: 2
2007high 93 (2021) · low 0 (2007)2025

MAUDE reports naming product code QII, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—02
20210—093
20220—059
20230—062
20240—018
20250—02
20260—0—
FIG. 1 — QII by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QII? 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 predicates do QII devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc. · 20191cites it

Which QII devices have the deepest lineage?

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

  • K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc. · 20193generations

What has FDA decided in QII lately?

  • K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemDexcom, Inc. · 2019

The one QII decision →

Related product codes

Other codes under 21 CFR 862.1355.

SAF Integrated Continuous Glucose Monitor For…QDK Integrated Continuous Glucose Monitoring…QDL Integrated Continuous Glucose Monitoring…SBH Integrated Continuous Glucose Monitor For…QLG Integrated Continuous Glucose Monitoring…QBJ Integrated Continuous Glucose Monitoring…