Company · SG
Epic Medical Pte. , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 12, 2026 | K252987 | ADRx Admixture Device Epic Medical Pte. , Ltd., SG | LHI |
| Apr 24, 2026 | K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) Epic Medical Pte. , Ltd., SG | MEB |
| Dec 5, 2025 | K251722 | ProSeal Transfer Injector (421120, 421130, 421140) Epic Medical Pte. , Ltd., SG | ONB |
| Aug 29, 2025 | K251814 | EZ IV Administration Set Epic Medical Pte. , Ltd., SG | FPA |
| Aug 1, 2025 | K252094 | eZSURE Empty Fluid Container Epic Medical Pte. , Ltd., SG | KPE |
| May 29, 2025 | K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) Epic Medical Pte. , Ltd., SG | ONB |
| Jan 22, 2025 | K243976 | ZeroClear Bag Access (423100) Epic Medical Pte. , Ltd., SG | ONB |
| Dec 26, 2024 | K240517 | ProSeal Vented Universal Vial Adaptor Epic Medical Pte. , Ltd., SG | ONB |
| Oct 23, 2024 | K241988 | ProSeal Closed System Bag Access Epic Medical Pte. , Ltd., SG | ONB |
| Oct 10, 2024 | K241735 | ProSeal In Line Pump Set (423850) Epic Medical Pte. , Ltd., SG | ONB |
| Oct 7, 2024 | K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) Epic Medical Pte. , Ltd., SG | MEB |
| Aug 30, 2024 | K241823 | ToxiSeal Vial Adaptor Epic Medical Pte. , Ltd., SG | ONB |
| Jun 21, 2024 | K241476 | ToxiSeal Vial Adaptor with External Flip Balloon Epic Medical Pte. , Ltd., SG | ONB |
| Jun 21, 2024 | K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site Epic Medical Pte. , Ltd., SG | KPE |
| May 21, 2024 | K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) Epic Medical Pte. , Ltd., SG | ONB |
| Mar 28, 2024 | K240171 | ProSeal Injector Plus (Model no. 421050) Epic Medical Pte. , Ltd., SG | ONB |
| Jan 11, 2024 | K222929 | ToxiSeal Vial Adapter with External Balloon Epic Medical Pte. , Ltd., SG | ONB |
| Nov 3, 2023 | K230343 | ProSeal Closed System Administration Set Epic Medical Pte. , Ltd., SG | FPA |
| Sep 1, 2023 | K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) Epic Medical Pte. , Ltd., SG | KPE |
| Mar 24, 2021 | K201626 | Safety Subcutaneous Infusion Set Epic Medical Pte. , Ltd., SG | FPA |
| Aug 7, 2020 | K192075 | ProSeal Closed System drug Transfer Device (CSTD) Epic Medical Pte. , Ltd., SG | ONB |
| Apr 4, 2016 | K151650 | SMARTez elastomeric infusion pump Epic Medical Pte. , Ltd., SG | MEB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||