FDA product code · Clinical chemistry
Sensor, Glucose, Invasive
8 FDA decisions since 1999. 25 recalls name this code, 0 of them Class I.
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MDS 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 · MDS
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MDS
Too few MDS 510(k)s in any year since 2007 to give a median.
Recalls per year · MDS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDS
2,803in 2025
MAUDE reports naming product code MDS, 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 | 11 | — | 0 | 14 |
| 2008 | 33 | — | 1 | 20 |
| 2009 | 35 | — | 20 | 127 |
| 2010 | 37 | — | 0 | 4,957 |
| 2011 | 24 | — | 0 | 6,450 |
| 2012 | 31 | — | 0 | 1,821 |
| 2013 | 29 | — | 0 | 683 |
| 2014 | 40 | — | 0 | 36,209 |
| 2015 | 45 | — | 0 | 39,944 |
| 2016 | 52 | — | 0 | 97,212 |
| 2017 | 40 | — | 0 | 48,848 |
| 2018 | 79 | — | 0 | 9,085 |
| 2019 | 47 | — | 1 | 2,127 |
| 2020 | 14 | — | 1 | 935 |
| 2021 | 13 | — | 0 | 590 |
| 2022 | 8 | — | 1 | 10,571 |
| 2023 | 3 | — | 0 | 13,881 |
| 2024 | 4 | — | 0 | 4,138 |
| 2025 | 7 | — | 1 | 2,803 |
| 2026 | 5 | — | 0 | — |
Planning a device in MDS? 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