FDA product code · Clinical chemistry
Automated Insulin Dosing Device System, Single Hormonal Control
1 FDA decision since 2016. 9 recalls name this code, 4 of them Class I.
An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OZP 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 · OZP
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZP
Too few OZP 510(k)s in any year since 2007 to give a median.
Recalls per year · OZP
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · OZP
150,968in 2025
MAUDE reports naming product code OZP, 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 | 13 |
| 2016 | 7 | — | 0 | 63 |
| 2017 | 15 | — | 0 | 3,606 |
| 2018 | 28 | — | 0 | 30,849 |
| 2019 | 21 | — | 3 (3) | 55,507 |
| 2020 | 8 | — | 1 | 74,042 |
| 2021 | 6 | — | 0 | 66,221 |
| 2022 | 7 | — | 2 | 154,932 |
| 2023 | 7 | — | 1 | 145,198 |
| 2024 | 7 | — | 1 (1) | 129,584 |
| 2025 | 14 | — | 0 | 150,968 |
| 2026 | 6 | — | 1 | — |
Planning a device in OZP? 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