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510(k) K210258

NovoFine by Novo Nordisk, Inc. — Product Code FMI

K210258 is an FDA 510(k) premarket notification submitted by Novo Nordisk, Inc. for the device "NovoFine". The FDA issued a decision of Substantially Equivalent on June 23, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Novo Nordisk, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2021
Date Received
February 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Novo Nordisk, Inc.

  • K231255 — NovoFine® Plus (August 25, 2023)
  • K202005 — NovoFine Plus 32G Tip x 4 mm (December 19, 2020)
  • K182387 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (December 17, 2018)
  • 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 FMI

  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)

FDA data resources