Home / 510(k) Clearances / K982842

510(k) K982842

HUMAPEN AND HUMAPEN ERGO by Eli Lilly and Co. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1998
Date Received
August 12, 1998
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 Eli Lilly and Co.

  • K212217 — Tempo Smart Button (September 16, 2022)
  • K160949 — Go Dose System (December 22, 2016)
  • K142518 — HumaPen Luxura (June 5, 2015)
  • K100988 — HUMAPEN LUXURA HD (August 17, 2010)
  • K063151 — HUMAPEN LUXURA HD (January 9, 2007)
  • K053563 — HUMAPEN MEMOIR (April 7, 2006)

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)