Closed System Transfer Device
FDA 510(k) K201460 · Shinva Ande Healthcare Apparatus Co., Ltd.
510(k) numberK201460
Submission
- Device name
- Closed System Transfer Device
- Applicant
- Shinva Ande Healthcare Apparatus Co., Ltd.
Zibo, CN - Received
- June 2, 2020
- Decision date
- November 23, 2022
- 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.
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| 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 |
|---|---|---|
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for…MEG · Traditional | 10/07/2022SE |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle…MEG · Traditional | 03/01/2022SE |
| K202060 | Disposable IV catheterFOZ · Traditional | 07/23/2021SE |
| K193657 | Disposable Enteral Feeding Syringe with Enfit ConnectorPNR · Traditional | 09/12/2020SE |
| K162601 | Infusion Set for Single UseFPA · Traditional | 05/31/2017SE |
Questions and answers
When was Closed System Transfer Device cleared by the FDA?
Closed System Transfer Device (K201460) received a 510(k) decision of Substantially Equivalent on November 23, 2022, 904 days after the submission was received.
What is the product code of K201460?
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.