FDA product code OYC: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
OYC is the FDA product code for pump, infusion, insulin, to be used with invasive glucose sensor. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under OYC reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 34 recalls for OYC devices, 18 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OYC devices
34 product recalls in 11 recall events; 18 initiated in the last five years and 29 still open. Most recent: 2026-02-13.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 10 |
| 2022 | 5 |
| 2024 | 1 |
| 2025 | 6 |
| 2026 | 6 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
- A4220 — Refill kit for implantable infusion pump
Frequently asked questions
What is FDA product code OYC?
OYC is the FDA product code for pump, infusion, insulin, to be used with invasive glucose sensor. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is OYC?
Class III. Typical premarket route: PMA.
Have OYC devices been recalled?
Yes: 34 product recalls across 11 recall events; the most recent began 2026-02-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OYC
- Run a recall and safety report across every OYC manufacturer
- Watch product code OYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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