MEB
- Product code
- MEB
- Device name
- Pump, Infusion, Elastomeric
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 88 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250234 | 2026-04-24 | Epic Medical Pte. , Ltd. | SMARTeZ Elastomeric Infusion Pump (RS series) | |
| K240624 | 2024-11-05 | First Medical Source, LLC | InfuLife | |
| K242152 | 2024-10-07 | Epic Medical Pte. , Ltd. | SMARTeZ Elastomeric Infusion Pump (498111, 498121, … |
Official FDA classification page: MEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).