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510(k) K213015

DORA Disposable A.V. Fistula Needle Sets by Bain Medical Equipment (Guangzhou) Co., Ltd. — Product Code FIE

K213015 is an FDA 510(k) premarket notification submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. for the device "DORA Disposable A.V. Fistula Needle Sets". The FDA issued a decision of Substantially Equivalent on April 8, 2022. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Bain Medical Equipment (Guangzhou) Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.

  • K252423 — NovaLine Tubing Set for Hemodialysis (BL 124) (May 15, 2026)
  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K203524 — Surgical Masks (February 25, 2021)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)

Other clearances for product code FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)
  • K111948 — WINGEATER V2 (October 24, 2011)

FDA data resources