Neoshield
FDA 510(k) K172499 · JMS North America Corporation
510(k) numberK172499
Submission
- Device name
- Neoshield
- Applicant
- JMS North America Corporation
Hayward, CA, US - Received
- August 18, 2017
- Decision date
- June 1, 2018
- 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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| K251722 | ProSeal Transfer Injector (421120, 421130, 421140)ONB · Special | Epic Medical Pte. , Ltd. | 12/05/2025SE |
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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 |
|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | 08/15/2025SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | 05/13/2015SE |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)FIE · Special | 12/23/2014SE |
| K132321 | JMS SyringeFMF · Traditional | 02/20/2014SE |
| K121488 | JMS Safe Wing Cath (SWC)FOZ · Traditional | 03/05/2013SE |
| K112178 | JMS Apheresis Needle Set Wingeater(R) V2FIE · Special | 10/27/2011SE |
| K111948 | Wingeater V2FIE · Special | 10/24/2011SE |
| K110157 | Sysloc Mini V3FIE · Special | 02/11/2011SE |
| K093637 | JMS Blunt A. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300…FIE · Traditional | 02/09/2010SE |
| K082882 | A.V. Fistula Blunt Needle SetFIE · Traditional | 01/21/2009SE |
Questions and answers
When was Neoshield cleared by the FDA?
Neoshield (K172499) received a 510(k) decision of Substantially Equivalent on June 1, 2018, 287 days after the submission was received.
What is the product code of K172499?
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.