SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
FDA 510(k) K242152 · Epic Medical Pte. , Ltd.
510(k) numberK242152
Submission
- Device name
- SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
- Applicant
- Epic Medical Pte. , Ltd.
Singapore, SG - Received
- July 23, 2024
- Decision date
- October 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series)MEB · Traditional | Epic Medical Pte. , Ltd. | 04/24/2026SE |
| K240624 | InfuLifeMEB · Traditional | First Medical Source, LLC | 11/05/2024SE |
| K181360 | ON-Q* Pump with BolusMEB · Traditional | Halyard Health | 03/22/2019SE |
| K151650 | SMARTez elastomeric infusion pumpMEB · Traditional | Epic Medical Pte. , Ltd. | 04/04/2016SE |
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | I-Flow, LLC | 02/03/2014SE |
| K131247 | Multibolus II Disposable Pain Management SystemMEB · Traditional | Mfs - Medical Flow Systems, Ltd. | 08/14/2013SE |
| K090300 | Modification to AutofuserMEB · Special | Ace Medical Us, LLC | 04/30/2009SE |
| K081905 | Accuflow and Accuflux Elastomeric Infusion PumpMEB · Traditional | Westmed, Inc. | 07/15/2008SE |
| K071532 | Alpha Infusion Pump, Model A200, A450MEB · Traditional | Advanced Infusion, Inc. | 02/19/2008SE |
| K072921 | Disposable Infusion Pump Kit, Go Pump Rapid Recovery SystemMEB · Special | Symbios Medical Products, LLC | 11/26/2007SE |
More from Symbios Medical Products, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | 06/12/2026SE |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series)MEB · Traditional | 04/24/2026SE |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140)ONB · Special | 12/05/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | 08/29/2025SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | 08/01/2025SE |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370)ONB · Special | 05/29/2025SE |
| K243976 | ZeroClear Bag Access (423100)ONB · Special | 01/22/2025SE |
| K240517 | ProSeal Vented Universal Vial AdaptorONB · Traditional | 12/26/2024SE |
| K241988 | ProSeal Closed System Bag AccessONB · Traditional | 10/23/2024SE |
| K241735 | ProSeal In Line Pump Set (423850)ONB · Special | 10/10/2024SE |
Questions and answers
When was SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) cleared by the FDA?
SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (K242152) received a 510(k) decision of Substantially Equivalent on October 7, 2024, 76 days after the submission was received.
What is the product code of K242152?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.