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510(k) K232950

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle by Perfect Medical Industry (Vn) Co., Ltd. — Product Code FMF

K232950 is an FDA 510(k) premarket notification submitted by Perfect Medical Industry (Vn) Co., Ltd. for the device "Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle". The FDA issued a decision of Substantially Equivalent on June 12, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
September 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

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  • 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)
  • K250853 — Merit Syringe (November 4, 2025)

FDA data resources