FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
SMARTeZ Elastomeric Infusion Pump (RS series)
K Number: K250234
·
Decision Apr 24, 2026
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
22
Review Days
452
Basic Information
- Device Name
- SMARTeZ Elastomeric Infusion Pump (RS series)
- K Number
- K250234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epic Medical Pte. , Ltd.
- Date Received
- January 27, 2025
- Decision Date
- April 24, 2026
- Product Code
- MEB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEB), ordered by most recent decision date.
InfuLife
FDA 510(k)
FDA Class 2
·General Hospital
SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
FDA 510(k)
FDA Class 2
·General Hospital
ON-Q* Pump with Bolus
FDA 510(k)
FDA Class 2
·General Hospital
SMARTez elastomeric infusion pump
FDA 510(k)
FDA Class 2
·General Hospital
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
FDA 510(k)
FDA Class 2
·General Hospital
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Epic Medical Pte. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252987 | ADRx Admixture Device | Jun 12, 2026 | Substantially Equivalent |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | Dec 5, 2025 | Substantially Equivalent |
| K251814 | EZ IV Administration Set | Aug 29, 2025 | Substantially Equivalent |
| K252094 | eZSURE Empty Fluid Container | Aug 1, 2025 | Substantially Equivalent |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | May 29, 2025 | Substantially Equivalent |
| K243976 | ZeroClear Bag Access (423100) | Jan 22, 2025 | Substantially Equivalent |
| K240517 | ProSeal Vented Universal Vial Adaptor | Dec 26, 2024 | Substantially Equivalent |
| K241988 | ProSeal Closed System Bag Access | Oct 23, 2024 | Substantially Equivalent |
| K241735 | ProSeal In Line Pump Set (423850) | Oct 10, 2024 | Substantially Equivalent |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Oct 7, 2024 | Substantially Equivalent |