Chrysalis Intelligence · Sponsors · Epic Medical Pte. , Ltd.

Epic Medical Pte. , Ltd.

Singapore, SG · 21 510(k) clearances

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Total clearances
21
2020-08-07 → 2026-06-12
Last 12 months
3
Product codes
5
Most recent
2026-06-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Class II General Hospital 12 2025-12-05
FPA Set, Administration, Intravascular Class II General Hospital 3 2025-08-29
KPE Container, I.V. Class II General Hospital 3 2025-08-01
MEB Pump, Infusion, Elastomeric Class II General Hospital 2 2026-04-24
LHI Set, I.V. Fluid Transfer Class II General Hospital 1 2026-06-12
Filings

All 510(k) clearances (21)

Date K-number Device Code Class Specialty
2026-06-12 K252987 ADRx™ Admixture Device LHI Class II General Hospital
2026-04-24 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series) MEB Class II General Hospital
2025-12-05 K251722 ProSeal™ Transfer Injector (421120, 421130, 421140) ONB Class II General Hospital
2025-08-29 K251814 EZ™ IV Administration Set FPA Class II General Hospital
2025-08-01 K252094 eZSURE™ Empty Fluid Container KPE Class II General Hospital
2025-05-29 K251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370) ONB Class II General Hospital
2025-01-22 K243976 ZeroClear™ Bag Access (423100) ONB Class II General Hospital
2024-12-26 K240517 ProSeal™ Vented Universal Vial Adaptor ONB Class II General Hospital
2024-10-23 K241988 ProSeal™ Closed System Bag Access ONB Class II General Hospital
2024-10-10 K241735 ProSeal™ In Line Pump Set (423850) ONB Class II General Hospital
2024-10-07 K242152 SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) MEB Class II General Hospital
2024-08-30 K241823 ToxiSeal™ Vial Adaptor ONB Class II General Hospital
2024-06-21 K241476 ToxiSeal™ Vial Adaptor with External Flip Balloon ONB Class II General Hospital
2024-06-21 K241442 eZSURE™ Empty Fluid Container with ProSeal™ Injection Site KPE Class II General Hospital
2024-05-21 K240433 ProSeal™ Injection Site Extended Male Luer Lock (422140) ONB Class II General Hospital
2024-03-28 K240171 ProSeal™ Injector Plus (Model no. 421050) ONB Class II General Hospital
2024-01-11 K222929 ToxiSeal Vial Adapter with External Balloon ONB Class II General Hospital
2023-11-03 K230343 ProSeal™ Closed System Administration Set FPA Class II General Hospital
2023-09-01 K223674 eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) KPE Class II General Hospital
2021-03-24 K201626 Safety Subcutaneous Infusion Set FPA Class II General Hospital
2020-08-07 K192075 ProSeal™ Closed System drug Transfer Device (CSTD) ONB Class II General Hospital
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence