FDA product code · Clinical chemistry
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
2 FDA decisions since 2014. 5 recalls name this code, 1 of them Class I.
The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OYC 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 · OYC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · OYC
Too few OYC 510(k)s in any year since 2007 to give a median.
Recalls per year · OYC
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OYC
12,223in 2025
MAUDE reports naming product code OYC, 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 | 34 |
| 2008 | 0 | — | 0 | 54 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 7,387 |
| 2013 | 0 | — | 0 | 14,265 |
| 2014 | 1 | — | 0 | 64,913 |
| 2015 | 1 | — | 2 | 105,309 |
| 2016 | 17 | — | 0 | 96,960 |
| 2017 | 13 | — | 0 | 132,643 |
| 2018 | 9 | — | 0 | 106,242 |
| 2019 | 2 | — | 0 | 99,202 |
| 2020 | 0 | — | 0 | 74,582 |
| 2021 | 0 | — | 0 | 50,917 |
| 2022 | 0 | — | 1 | 77,938 |
| 2023 | 0 | — | 0 | 24,388 |
| 2024 | 0 | — | 1 (1) | 17,602 |
| 2025 | 0 | — | 0 | 12,223 |
| 2026 | 0 | — | 0 | — |
Planning a device in OYC? 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