FDA product code · Clinical chemistry
Pump, Infusion, Insulin Bolus
7 FDA decisions since 2010. 510(k) reviews decided 2021–2025 took a median of 60 days (half between 44 and 75). 1 recall names this code; it is not Class I. The most-cited predicate is K093065, named by 3 later devices.
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OPP 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 · OPP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OPP
Too few OPP 510(k)s in any year since 2007 to give a median.
Recalls per year · OPP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OPP
1in 2025
MAUDE reports naming product code OPP, 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 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 22 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
Planning a device in OPP? 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) ReportRelated product codes
Other codes under 21 CFR 880.5725.