ProSeal Bag Spike with Additive Port (423370ST, 423370)
FDA 510(k) K251340 · Epic Medical Pte. , Ltd.
510(k) numberK251340
Submission
- Device name
- ProSeal Bag Spike with Additive Port (423370ST, 423370)
- Applicant
- Epic Medical Pte. , Ltd.
Singapore, SG - Received
- April 30, 2025
- Decision date
- May 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Other 510(k)s with product code ONB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140)ONB · Special | Epic Medical Pte. , Ltd. | 12/05/2025SE |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorONB · Special | Simplivia Healthcare , Ltd. | 10/21/2025SE |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)ONB · Traditional | Becton, Dickinson and Company | 09/12/2025SE |
| K251411 | Chemfort Female Luer Lock AdaptorONB · Traditional | Simplivia Healthcare , Ltd. | 08/05/2025SE |
| K243976 | ZeroClear Bag Access (423100)ONB · Special | Epic Medical Pte. , Ltd. | 01/22/2025SE |
| K240517 | ProSeal Vented Universal Vial AdaptorONB · Traditional | Epic Medical Pte. , Ltd. | 12/26/2024SE |
| K241988 | ProSeal Closed System Bag AccessONB · Traditional | Epic Medical Pte. , Ltd. | 10/23/2024SE |
| K241735 | ProSeal In Line Pump Set (423850)ONB · Special | Epic Medical Pte. , Ltd. | 10/10/2024SE |
| K241823 | ToxiSeal Vial AdaptorONB · Special | Epic Medical Pte. , Ltd. | 08/30/2024SE |
| K241476 | ToxiSeal Vial Adaptor with External Flip BalloonONB · Special | Epic Medical Pte. , Ltd. | 06/21/2024SE |
More from Epic Medical Pte. , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | 06/12/2026SE |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series)MEB · Traditional | 04/24/2026SE |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140)ONB · Special | 12/05/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | 08/29/2025SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | 08/01/2025SE |
| K243976 | ZeroClear Bag Access (423100)ONB · Special | 01/22/2025SE |
| K240517 | ProSeal Vented Universal Vial AdaptorONB · Traditional | 12/26/2024SE |
| K241988 | ProSeal Closed System Bag AccessONB · Traditional | 10/23/2024SE |
| K241735 | ProSeal In Line Pump Set (423850)ONB · Special | 10/10/2024SE |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)MEB · Special | 10/07/2024SE |
Questions and answers
When was ProSeal Bag Spike with Additive Port (423370ST, 423370) cleared by the FDA?
ProSeal Bag Spike with Additive Port (423370ST, 423370) (K251340) received a 510(k) decision of Substantially Equivalent on May 29, 2025, 29 days after the submission was received.
What is the product code of K251340?
The FDA product code is ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, a Class II (moderate risk) device regulated under 21 CFR 880.5440.