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510(k) K162180

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

K162180 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Disposable Insulin Syringe". The FDA issued a decision of Substantially Equivalent on December 29, 2016. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Berpu Medical Technology Co., Ltd. has at least 8 other 510(k) clearances on record.

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

  • K262581 — GraftGun Universal Graft Delivery System (GDS®) (August 26, 2026)
  • K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray (August 25, 2026)
  • K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (August 14, 2026)
  • 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)

FDA data resources