FDA product code · Clinical chemistry
Interoperable Automated Glycemic Controller
25 FDA decisions since 2019. 510(k) reviews decided 2021–2025 took a median of 176 days (half between 78 and 267). No recall names this code. The most-cited predicate is K200467, named by 4 later devices.
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QJI 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 · QJI
8so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJI
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJI
No recall names QJI since 2007.
Adverse event reports per year · QJI
3in 2025
MAUDE reports naming product code QJI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 4 | 251 | 0 | 26 |
| 2024 | 4 | 174 | 0 | 15 |
| 2025 | 5 | 130 | 0 | 3 |
| 2026 | 8 | 65 | 0 | — |
Planning a device in QJI? 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) ReportRelated product codes
Other codes under 21 CFR 862.1356.