Epic Medical Pte. , Ltd.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Epic Medical Pte. , Ltd.” (first 2016, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 107 days, against 223 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 291 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 371 |
| 2021 | 1 | 281 |
| 2022 | 0 | — |
| 2023 | 2 | 268 |
| 2024 | 10 | 86 |
| 2025 | 5 | 30 |
| 2026 | 2 | 360 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Epic Medical Pte. , Ltd. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 12 | 12 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| KPE | Container, I.V. | 3 | 3 |
| MEB | Pump, Infusion, Elastomeric | 3 | 3 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
- General Hospital (22)
Most recent Epic Medical Pte. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252987 | ADRx Admixture Device | LHI | 2026-06-12 | 267 |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | MEB | 2026-04-24 | 452 |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | ONB | 2025-12-05 | 184 |
| K251814 | EZ IV Administration Set | FPA | 2025-08-29 | 77 |
| K252094 | eZSURE Empty Fluid Container | KPE | 2025-08-01 | 29 |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | ONB | 2025-05-29 | 29 |
| K243976 | ZeroClear Bag Access (423100) | ONB | 2025-01-22 | 30 |
| K240517 | ProSeal Vented Universal Vial Adaptor | ONB | 2024-12-26 | 307 |
| K241988 | ProSeal Closed System Bag Access | ONB | 2024-10-23 | 107 |
| K241735 | ProSeal In Line Pump Set (423850) | ONB | 2024-10-10 | 115 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Epic Medical Pte. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Epic Medical Pte. , Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Epic Medical Equipment Services, Inc. (13 510(k)s)
- Epic Extremity, LLC (5 510(k)s)
- Epic Systems, Inc. (4 510(k)s)
- Epic Extremely, LLC (1 510(k)s)
- Epic Medical Concepts & Innovations (1 510(k)s)
- Epic Research & Diagnostics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Epic Medical Pte. , Ltd.?
FDA lists 22 510(k) clearances under the applicant name “Epic Medical Pte. , Ltd.” (first 2016, latest 2026), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Epic Medical Pte. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epic Medical Pte. , Ltd. is 111 days. Since 2017: 107 days, versus 223 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Epic Medical Pte. , Ltd.?
The most frequent FDA product codes under this applicant name are ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, 12); FPA (Set, Administration, Intravascular, 3); KPE (Container, I.V., 3).
Next steps
- See all 22 Epic Medical Pte. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ONB, Epic Medical Pte. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.