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510(k) K220061

Safety Insulin Syringes by Berpu Medical Technology Co., Ltd. — Product Code MEG

K220061 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Safety Insulin Syringes". The FDA issued a decision of Substantially Equivalent on August 23, 2022. The device falls under product code MEG (Syringe, Antistick), 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
August 23, 2022
Date Received
January 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Antistick
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)
  • 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)
  • K162180 — Disposable Insulin Syringe (December 29, 2016)

Other clearances for product code MEG

  • K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (February 18, 2026)
  • K250847 — VaporShield (December 12, 2025)
  • K230287 — SaviSafe Safety Device (November 21, 2023)
  • K231165 — Shina Syringe; Shina Safety Syringe (October 27, 2023)
  • K231907 — Medline Safety Insulin and TB Syringes (October 18, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K220114 — PowerPAK Syringe (January 25, 2023)
  • K221981 — SafeR Syringe and SafeR Sting (December 29, 2022)
  • K222452 — Disposable Automatically Retractable Safety Syringes (with detachable needle) (November 23, 2022)
  • K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with N (November 1, 2022)

FDA data resources