Home / 510(k) Clearances / K190427

510(k) K190427

Immucise by Terumo Corporation — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2019
Date Received
February 22, 2019
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 Terumo Corporation

  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K250751 — DualView Catheter (July 17, 2025)
  • K240818 — R2P Radifocus Glidewire Advantage (November 26, 2024)
  • K240859 — Glidewire GT-R (August 21, 2024)
  • K181369 — Immucise Intradermal Injection System (November 13, 2018)
  • K173799 — NaviCross 0.018 (March 29, 2018)
  • K170417 — Glidewire GT (September 15, 2017)
  • K130493 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR (March 13, 2013)
  • K130280 — CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR (March 13, 2013)
  • K122544 — TERUMO SURFLASH SAFETY I.V. CATHETER (September 5, 2012)

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)