FDA product code OPP: Pump, Infusion, Insulin Bolus
OPP is the FDA product code for pump, infusion, insulin bolus. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under OPP, 3 in the last five years, from 3 different applicants. The average 510(k) review took 144 days (median 112); 142 days on average over the last three years. FDA has posted 1 recall for OPP devices.
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Insulin Bolus |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for OPP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 189 |
| 2024 | 2 | 60 |
| 2026 | 1 | 224 |
Compare with all 510(k) review times · Search every OPP clearance
Top OPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cequr SA | 3 | 2026-04-10 |
| Calibra Medical, Inc. | 3 | 2012-04-10 |
| Lifescan Europe, A Division of Cilag GmbH | 1 | 2017-06-07 |
Most recent OPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252757 | Cequr SA | CeQur Simplicity On-Demand Insulin Delivery System | 2026-04-10 | 224 |
| K243273 | Cequr SA | CeQur Simplicity On-Demand Insulin Delivery System | 2024-11-13 | 28 |
| K233447 | Cequr SA | CeQur Simplicity On-Demand Insulin Delivery System | 2024-01-18 | 91 |
| K163357 | Lifescan Europe, A Division of Cilag GmbH | OneTouch Via On-Demand Insulin Delivery System | 2017-06-07 | 189 |
| K111924 | Calibra Medical, Inc. | FINESSE PERSONAL INSULIN DELIVERY PATCH | 2012-04-10 | 279 |
Recalls for OPP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-06-13.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code OPP?
OPP is the FDA product code for pump, infusion, insulin bolus. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the Clinical Chemistry panel.
What device class is OPP?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPP?
Across 7 cleared submissions the average was 144 days from receipt to decision (median 112).
Which companies have the most OPP clearances?
Cequr SA (3); Calibra Medical, Inc. (3); Lifescan Europe, A Division of Cilag GmbH (1).
Have OPP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-06-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OPP
- Run a recall and safety report across every OPP manufacturer
- Watch product code OPP 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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