JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
FDA 510(k) K142564 · JMS North America Corporation
510(k) numberK142564
Submission
- Device name
- JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
- Applicant
- JMS North America Corporation
Hayward, CA, US - Received
- September 11, 2014
- Decision date
- December 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIE – Needle, Fistula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FIE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus…FIE · Traditional | Mozarc Medical Us, LLC | 08/06/2026SE |
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | JMS North America Corporation | 08/15/2025SE |
| K213015 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 04/08/2022SE |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV…FIE · Traditional | Dimesol, Inc. | 05/17/2018SE |
| K163025 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 07/20/2017SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | JMS North America Corporation | 05/13/2015SE |
| K131950 | Angel Tip Safety Intravascular Needle SetFIE · Traditional | Summit International Medical Technologies, Inc. | 01/16/2015SE |
| K134019 | Medisystems Onesite Dual Lumen Needle with Masterguard Anti-Stick Needle Protector…FIE · Traditional | Nxstage Medical, Inc. | 09/11/2014SE |
| K112734 | Aplan A.V. Fistula Needle SetFIE · Traditional | Aplan Well Enterprise Co., Ltd. | 04/24/2012SE |
| K112178 | JMS Apheresis Needle Set Wingeater(R) V2FIE · Special | JMS North America Corporation | 10/27/2011SE |
More from JMS North America Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251877 | JMS CAVEO A.V. Fistula Needle SetFIE · Traditional | 08/15/2025SE |
| K172499 | NeoshieldONB · Traditional | 06/01/2018SE |
| K151017 | JMS Harmony A.V. Fistula Needle SetFIE · Special | 05/13/2015SE |
| 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 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) cleared by the FDA?
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (K142564) received a 510(k) decision of Substantially Equivalent on December 23, 2014, 103 days after the submission was received.
What is the product code of K142564?
The FDA product code is FIE – Needle, Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.