Home / 510(k) Clearances / K162180

510(k) K162180

Disposable Insulin Syringe by Berpu Medical Technology Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2016
Date Received
August 4, 2016
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 Berpu Medical Technology Co., Ltd.

  • K232165 — Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for (February 1, 2024)
  • K221045 — Insulin Syringes without needle (November 3, 2022)
  • K220061 — Safety Insulin Syringes (August 23, 2022)
  • K213158 — Syringe with permanently attached needle (July 21, 2022)
  • K213811 — Sterile Hypodermic Syringes for Single Use (May 12, 2022)
  • K212514 — Safety Pen Needle for Single Use, Insulin Pen Needles (April 29, 2022)
  • K181447 — Safety insulin needle for single use (March 12, 2019)
  • K180417 — Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for (August 9, 2018)

Other clearances for product code FMF

  • 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)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K252033 — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (July 25, 2025)