ZeroClear Bag Access (423100)
FDA 510(k) K243976 · Epic Medical Pte. , Ltd.
510(k) numberK243976
Submission
- Device name
- ZeroClear Bag Access (423100)
- Applicant
- Epic Medical Pte. , Ltd.
Singapore, SG - Received
- December 23, 2024
- Decision date
- January 22, 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 |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370)ONB · Special | Epic Medical Pte. , Ltd. | 05/29/2025SE |
| 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 |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370)ONB · Special | 05/29/2025SE |
| 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 ZeroClear Bag Access (423100) cleared by the FDA?
ZeroClear Bag Access (423100) (K243976) received a 510(k) decision of Substantially Equivalent on January 22, 2025, 30 days after the submission was received.
What is the product code of K243976?
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.