FDA product code · Clinical chemistry
Automated Insulin Dosing , Threshold Suspend
3 FDA decisions since 2013. 5 recalls name this code, 2 of them Class I.
An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump 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 OZO 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 · OZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZO
Too few OZO 510(k)s in any year since 2007 to give a median.
Recalls per year · OZO
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · OZO
3,599in 2025
MAUDE reports naming product code OZO, 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 | 3 | — | 0 | 0 |
| 2014 | 32 | — | 0 | 15,080 |
| 2015 | 35 | — | 0 | 28,763 |
| 2016 | 28 | — | 0 | 21,282 |
| 2017 | 29 | — | 1 | 30,435 |
| 2018 | 53 | — | 1 | 39,960 |
| 2019 | 31 | — | 1 (1) | 82,392 |
| 2020 | 8 | — | 1 | 77,812 |
| 2021 | 7 | — | 0 | 42,577 |
| 2022 | 9 | — | 0 | 54,924 |
| 2023 | 3 | — | 0 | 29,739 |
| 2024 | 2 | — | 1 (1) | 11,814 |
| 2025 | 1 | — | 0 | 3,599 |
| 2026 | 2 | — | 0 | — |
Planning a device in OZO? 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