DORA Disposable A.V. Fistula Needle Sets
FDA 510(k) K163025 · Bain Medical Equipment (Guangzhou) Co., Ltd.
510(k) numberK163025
Submission
- Device name
- DORA Disposable A.V. Fistula Needle Sets
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Guangzhou, CN - Received
- October 31, 2016
- Decision date
- July 20, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| 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 |
|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | 05/15/2026SE |
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | 06/28/2024SE |
| K213015 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | 04/08/2022SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | 03/10/2021SE |
| K203524 | Surgical MasksFXX · Traditional | 02/25/2021SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | 06/16/2017SE |
Questions and answers
When was DORA Disposable A.V. Fistula Needle Sets cleared by the FDA?
DORA Disposable A.V. Fistula Needle Sets (K163025) received a 510(k) decision of Substantially Equivalent on July 20, 2017, 262 days after the submission was received.
What is the product code of K163025?
The FDA product code is FIE – Needle, Fistula, a Class II (moderate risk) device regulated under 21 CFR 876.5540.