Home / 510(k) Clearances / K223323

510(k) K223323

Blood Collection Needle (with/without Needle Holder) by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2023
Date Received
October 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

  • K234024 — HWJECT Auto-disable syringe (March 19, 2024)
  • K230061 — Insulin Syringe (November 30, 2023)
  • K230043 — Insulin Pen Needle (September 20, 2023)
  • K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle (November 4, 2022)
  • K222141 — Safety Blood Collection Needle (Without Needle Holder) (October 21, 2022)
  • K220900 — Safety Blood Collection Needles with/without Needle Holder (August 10, 2022)
  • K220083 — LDV((Low Dead Volume )Syringe (May 25, 2022)
  • K214075 — Safety Blood Collection / Infusion Set (with/without needle holder), Blood Colle (April 12, 2022)
  • K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (October 18, 2021)
  • K202188 — Safety Blood Collection Sets for Single Use (February 19, 2021)

Other clearances for product code JKA

  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K251812 — Steripath® Flow™ Blood Collection System (September 25, 2025)
  • K243207 — BD Vacutainer® Eclipse™ Blood Collection Needle (July 3, 2025)
  • K250961 — Blood collection tube holders (June 4, 2025)
  • K244047 — Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (May 23, 2025)
  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K242320 — BD Vacutainer® One Use Holder (November 1, 2024)
  • K233979 — VACUETTE® QUICKSHIELD Complete (Plus) (July 19, 2024)