# Epic Medical Pte., Ltd.

- Location (FDA's records): Singapore, SG
- FDA decisions: 22 (2016–2026): 22 510(k) clearances
- Product codes: ONB (12), KPE (3), MEB (3), FPA (3), LHI (1)
- 510(k) review time since 2016: median 107 days, against 102 for FDA's reviews in the same codes and years (8 of 15 faster)
- Predicates its devices cite: 26 (14 its own); citations of its devices by later devices: 15 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- I-Flow Corp.: 2 (https://510kreport.com/company/i-flow)
- Shinva Ande Healthcare Apparatus Co., Ltd.: 1 (https://510kreport.com/company/shinva-ande-healthcare-apparatus)
- Valmed Corp.: 1 (https://510kreport.com/company/valmed)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Westmed, Inc.: 1 (https://510kreport.com/company/westmed)
- Emed Technologies Corporation: 1 (https://510kreport.com/company/emed-technologies)
- Yukon Medical, LLC: 1 (https://510kreport.com/company/yukon-medical)

## Firms that cite its devices most
- First Medical Source, LLC: 1 (https://510kreport.com/company/first-medical-source)

## Its most-cited devices
- K240171: ProSeal™ Injector Plus (Model no. 421050) (2024), cited by 3
- K151650: SMARTez elastomeric infusion pump (2016), cited by 3
- K241988: ProSeal™ Closed System Bag Access (2024), cited by 2
- K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (2023), cited by 2
- K222929: ToxiSeal Vial Adapter with External Balloon (2024), cited by 1
- K192075: ProSeal™ Closed System drug Transfer Device (CSTD) (2020), cited by 1

## Recent decisions
- K252987: ADRx™ Admixture Device (Jun 12, 2026)
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (Apr 24, 2026)
- K251722: ProSeal™ Transfer Injector (421120, 421130, 421140) (Dec 5, 2025)
- K251814: EZ™ IV Administration Set (Aug 29, 2025)
- K252094: eZSURE™ Empty Fluid Container (Aug 1, 2025)
- K251340: ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
- K243976: ZeroClear™ Bag Access (423100) (Jan 22, 2025)
- K240517: ProSeal™ Vented Universal Vial Adaptor (Dec 26, 2024)

Source page: https://510kreport.com/company/epic-medical