FDA product code · Clinical chemistry

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Name: FDA decisions, review times, recalls and adverse event reports for product code QDK
Creator: 510(k) Report

QDKClass II21 CFR 862.1355510(k) required4 decisions since 20180 recalls

4 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 308 days (half between 308 and 308). No recall names this code. The most-cited predicate is K203089, named by 1 later device.

An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended…

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 QDK 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 · QDK

1in 2021

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QDK

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

Recalls per year · QDK

No recall names QDK since 2007.

Adverse event reports per year · QDK

63in 2025

2007high 238 (2024) · low 0 (2007)2025

MAUDE reports naming product code QDK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	2
2019	1	—	26
2020	1	—	18
2021	1	—	111
2022	0	—	81
2023	0	—	78
2024	0	—	238
2025	0	—	63
2026	0	—	—

FIG. 1 — QDK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QDK? 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 862.1355.

SAF Integrated Continuous Glucose Monitor For…QII 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…

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Which predicates do QDK devices cite most?

Which QDK devices have the deepest lineage?

What has FDA decided in QDK lately?

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