FDA product code · Clinical chemistry
Continuous Glucose Monitor, Implanted, Adjunctive Use
1 FDA decision since 2018. No recall names this code.
The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QCD 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 · QCD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QCD
Too few QCD 510(k)s in any year since 2007 to give a median.
Recalls per year · QCD
No recall names QCD since 2007.
Adverse event reports per year · QCD
364in 2024
MAUDE reports naming product code QCD, 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 | 5 | — | 0 | 3 |
| 2019 | 4 | — | 0 | 270 |
| 2020 | 0 | — | 0 | 576 |
| 2021 | 0 | — | 0 | 157 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 115 |
| 2024 | 2 | — | 0 | 364 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in QCD? 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