JMS Harmony A.V. Fistula Needle Set
FDA 510(k) K151017 · JMS North America Corporation
510(k) numberK151017
Submission
- Device name
- JMS Harmony A.V. Fistula Needle Set
- Applicant
- JMS North America Corporation
Hayward, CA, US - Received
- April 16, 2015
- Decision date
- May 13, 2015
- 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 |
| K131950 | Angel Tip Safety Intravascular Needle SetFIE · Traditional | Summit International Medical Technologies, Inc. | 01/16/2015SE |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)FIE · Special | JMS North America Corporation | 12/23/2014SE |
| 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 |
| 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 JMS Harmony A.V. Fistula Needle Set cleared by the FDA?
JMS Harmony A.V. Fistula Needle Set (K151017) received a 510(k) decision of Substantially Equivalent on May 13, 2015, 27 days after the submission was received.
What is the product code of K151017?
The FDA product code is FIE – Needle, Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.