Epic Medical Pte., Ltd.
Singapore, SG
Epic Medical Pte. , Ltd. appears in FDA device records in Singapore, SG. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Epic Medical Pte., Ltd. between 2016 and 2026. The busiest year on record is 2024, with 10. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 10 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252987 | ADRx™ Admixture Device | LHI | Substantially Equivalent | |
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | MEB | Substantially Equivalent | |
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | ONB | Substantially Equivalent | |
| K251814 | EZ™ IV Administration Set | FPA | Substantially Equivalent | |
| K252094 | eZSURE™ Empty Fluid Container | KPE | Substantially Equivalent | |
| K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | ONB | Substantially Equivalent | |
| K243976 | ZeroClear™ Bag Access (423100) | ONB | Substantially Equivalent | |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | ONB | Substantially Equivalent | |
| K241988 | ProSeal™ Closed System Bag Access | ONB | Substantially Equivalent | |
| K241735 | ProSeal™ In Line Pump Set (423850) | ONB | Substantially Equivalent | |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | MEB | Substantially Equivalent | |
| K241823 | ToxiSeal™ Vial Adaptor | ONB | Substantially Equivalent | |
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | ONB | Substantially Equivalent | |
| K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | KPE | Substantially Equivalent | |
| K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | ONB | Substantially Equivalent | |
| K240171 | ProSeal™ Injector Plus (Model no. 421050) | ONB | Substantially Equivalent | |
| K222929 | ToxiSeal Vial Adapter with External Balloon | ONB | Substantially Equivalent | |
| K230343 | ProSeal™ Closed System Administration Set | FPA | Substantially Equivalent | |
| K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | KPE | Substantially Equivalent | |
| K201626 | Safety Subcutaneous Infusion Set | FPA | Substantially Equivalent | |
| K192075 | ProSeal™ Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | |
| K151650 | SMARTez elastomeric infusion pump | MEB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain