Home / 510(k) Clearances / K182387

510(k) K182387

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) by Novo Nordisk, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2018
Date Received
September 4, 2018
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 Novo Nordisk, Inc.

  • K231255 — NovoFine® Plus (August 25, 2023)
  • K210258 — NovoFine (June 23, 2021)
  • K202005 — NovoFine Plus 32G Tip x 4 mm (December 19, 2020)
  • K173479 — NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (January 17, 2018)
  • K162602 — NovoPen Echo (October 18, 2016)
  • K150874 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (July 31, 2015)
  • K133738 — NOVOFINE PLUS 32G 4 MM (May 21, 2014)
  • K123766 — NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN (August 15, 2013)
  • K093109 — NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (June 18, 2010)
  • K090111 — FLEXPEN NEEDLE (February 1, 2010)

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)