510(k) Report

FDA product code · Clinical chemistry

Interoperable Automated Glycemic Controller, Insulin Suspend

QJSClass II21 CFR 862.1356510(k) required1 decision since 20200 recalls

1 FDA decision since 2020. No recall names this code.

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption…

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 QJS 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 · QJS

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJS

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

Recalls per year · QJS

No recall names QJS since 2007.

Adverse event reports per year · QJS

1in 2022

2021: 22022: 1
2007high 2 (2021) · low 0 (2007)2025

MAUDE reports naming product code QJS, 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
20190—00
20201—00
20210—02
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QJS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QJS? 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 QJS devices have the deepest lineage?

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

  • K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 20209generations

What has FDA decided in QJS lately?

  • K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 20201 Class I recall

The one QJS decision →

Related product codes

Other codes under 21 CFR 862.1356.

QJI Interoperable Automated Glycemic Controller