Home / 510(k) Clearances / K192681

510(k) K192681

Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) by Jiangsu Kangbao Medical Equipment Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Jiangsu Kangbao Medical Equipment Co., Ltd.

  • K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Col (December 22, 2023)
  • K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with N (November 1, 2022)
  • K211329 — Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with N (November 15, 2021)
  • K182649 — Enteral Feeding Syringes with Enfit Connectors (November 9, 2018)

Other clearances for product code FPA

  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)