510(k) Report

FDA product code · Clinical chemistry

Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

QDLClass II21 CFR 862.1355510(k) required1 decision since 20180 recalls

1 FDA decision since 2018. No recall names this code. The most-cited predicate is K182405, named by 1 later device.

An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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 QDL 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 · QDL

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QDL

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

Recalls per year · QDL

No recall names QDL since 2007.

Adverse event reports per year · QDL

No MAUDE report names QDL 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
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QDL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QDL? 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 QDL devices cite most?

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

  • K182405Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. · 20181cites it

Which QDL devices have the deepest lineage?

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

  • K182405Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. · 20181generation

What has FDA decided in QDL lately?

  • K182405Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc. · 2018

The one QDL decision →

Related product codes

Other codes under 21 CFR 862.1355.

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