Home / 510(k) Clearances / K234024

510(k) K234024

HWJECT Auto-disable syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMF

K234024 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "HWJECT Auto-disable syringe". The FDA issued a decision of Substantially Equivalent on March 19, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2024
Date Received
December 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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

  • K230061 — Insulin Syringe (November 30, 2023)
  • K230043 — Insulin Pen Needle (September 20, 2023)
  • K223323 — Blood Collection Needle (with/without Needle Holder) (March 24, 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 FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources