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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 | 267 | 0 |
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 | 452 | 0 |
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | 2025-12-05 | 184 | 0 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 | 77 | 0 |
| K252094 | eZSURE™ Empty Fluid Container | Epic Medical Pte. , Ltd. | 2025-08-01 | 29 | 0 |
| K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | 2025-05-29 | 29 | 0 |
| K243976 | ZeroClear™ Bag Access (423100) | Epic Medical Pte. , Ltd. | 2025-01-22 | 30 | 0 |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-12-26 | 307 | 0 |
| K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte. , Ltd. | 2024-10-23 | 107 | 0 |
| K241735 | ProSeal™ In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | 2024-10-10 | 115 | 0 |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, | Epic Medical Pte. , Ltd. | 2024-10-07 | 76 | 0 |
| K241823 | ToxiSeal™ Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-08-30 | 67 | 0 |
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | 2024-06-21 | 28 | 0 |
| K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte. , Ltd. | 2024-06-21 | 30 | 0 |
| K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | 2024-05-21 | 97 | 0 |
| K240171 | ProSeal™ Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | 2024-03-28 | 66 | 0 |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | 2024-01-11 | 472 | 0 |
| K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte. , Ltd. | 2023-11-03 | 268 | 0 |
| K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110 | Epic Medical Pte. , Ltd. | 2023-09-01 | 268 | 0 |
| K201626 | Safety Subcutaneous Infusion Set | Epic Medical Pte. , Ltd. | 2021-03-24 | 281 | 0 |
| K192075 | ProSeal™ Closed System drug Transfer Device (CSTD) | Epic Medical Pte. , Ltd. | 2020-08-07 | 371 | 0 |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016-04-04 | 291 | 0 |
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