Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Epic Medical Pte. , Ltd. — Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

115 daysmedian FDA review time
371 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.2026-06-122670
K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.2026-04-244520
K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.2025-12-051840
K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.2025-08-29770
K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.2025-08-01290
K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.2025-05-29290
K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.2025-01-22300
K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte. , Ltd.2024-12-263070
K241988ProSeal™ Closed System Bag AccessEpic Medical Pte. , Ltd.2024-10-231070
K241735ProSeal™ In Line Pump Set (423850)Epic Medical Pte. , Ltd.2024-10-101150
K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, Epic Medical Pte. , Ltd.2024-10-07760
K241823ToxiSeal™ Vial AdaptorEpic Medical Pte. , Ltd.2024-08-30670
K241476ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte. , Ltd.2024-06-21280
K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.2024-06-21300
K240433ProSeal™ Injection Site Extended Male Luer Lock (422140)Epic Medical Pte. , Ltd.2024-05-21970
K240171ProSeal™ Injector Plus (Model no. 421050)Epic Medical Pte. , Ltd.2024-03-28660
K222929ToxiSeal Vial Adapter with External BalloonEpic Medical Pte. , Ltd.2024-01-114720
K230343ProSeal™ Closed System Administration SetEpic Medical Pte. , Ltd.2023-11-032680
K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110Epic Medical Pte. , Ltd.2023-09-012680
K201626Safety Subcutaneous Infusion SetEpic Medical Pte. , Ltd.2021-03-242810
K192075ProSeal™ Closed System drug Transfer Device (CSTD)Epic Medical Pte. , Ltd.2020-08-073710
K151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.2016-04-042910

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda