FDA product code · Clinical chemistry
Sensor, Glucose, Implanted, Non-Adjunctive Use
0 FDA decisions since 2019. 1 recall names this code; it is not Class I.
A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QHJ 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 · QHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHJ
Too few QHJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QHJ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QHJ
627in 2025
MAUDE reports naming product code QHJ, 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 | 6 | — | 1 | 0 |
| 2020 | 1 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 3 | — | 0 | 173 |
| 2023 | 5 | — | 0 | 341 |
| 2024 | 0 | — | 0 | 915 |
| 2025 | 1 | — | 0 | 627 |
| 2026 | 0 | — | 0 | — |
Planning a device in QHJ? 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