FDA product code SBA: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
SBA is the FDA product code for integrated continuous glucose monitoring system with sensor containing dexamethasone acetate. It is a Class II device, regulated under 21 CFR 862.1357 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under SBA, 1 in the last five years. The average 510(k) review took 126 days (median 126); 126 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate |
| Device class | Class II |
| Regulation | 21 CFR 862.1357 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SBA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 126 |
Compare with all 510(k) review times · Search every SBA clearance
Top SBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Senseonics, Incorporated | 1 | 2024-09-16 |
Most recent SBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241335 | Senseonics, Incorporated | Eversense 365 Continuous Glucose Monitoring (CGM) System | 2024-09-16 | 126 |
Recalls for SBA devices
openFDA lists no recalls for product code SBA.
Frequently asked questions
What is FDA product code SBA?
SBA is the FDA product code for integrated continuous glucose monitoring system with sensor containing dexamethasone acetate. It is a Class II device, regulated under 21 CFR 862.1357 and reviewed by the Clinical Chemistry panel.
What device class is SBA?
Class II, regulation 21 CFR 862.1357. Typical premarket route: 510(k).
How long does a 510(k) take for product code SBA?
Across 1 cleared submissions the average was 126 days from receipt to decision (median 126).
Which companies have the most SBA clearances?
Senseonics, Incorporated (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBA
- Run a recall and safety report across every SBA manufacturer
- Watch product code SBA 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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