Arisure Closed System Drug Transfer Device (CSTD)
FDA 510(k) K201422 · Yukon Medical, LLC
510(k) numberK201422
Submission
- Device name
- Arisure Closed System Drug Transfer Device (CSTD)
- Applicant
- Yukon Medical, LLC
Durham, NC, US - Received
- May 29, 2020
- Decision date
- March 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
More from Epic Medical Pte. , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | 03/21/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | 12/06/2024SE |
| K172884 | Arisure Closed Vial AdapterLHI · Traditional | 10/03/2017SE |
| K172631 | Arisure Dry SpikeLHI · Traditional | 09/29/2017SE |
| K171101 | Closed Male LuerFPA · Traditional | 06/02/2017SE |
| K151963 | SmartSite Vented Vial Access DeviceLHI · Traditional | 07/31/2015SE |
| K132863 | Smartsite VialshieldLHI · Traditional | 10/04/2013SE |
| K122265 | Vialok Single Vial Access Device VentedLHI · Traditional | 08/14/2012SE |
| K121182 | Vialok Non-VentedLHI · Traditional | 05/03/2012SE |
| K120799 | Arisure Neutral ValveFPA · Traditional | 03/30/2012SE |
Questions and answers
When was Arisure Closed System Drug Transfer Device (CSTD) cleared by the FDA?
Arisure Closed System Drug Transfer Device (CSTD) (K201422) received a 510(k) decision of Substantially Equivalent on March 2, 2021, 277 days after the submission was received.
What is the product code of K201422?
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.