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510(k) K993666

DISETRONIC PEN P100 by Disetronic Medical Systems — Product Code FMF

K993666 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DISETRONIC PEN P100". The FDA issued a decision of Substantially Equivalent on November 22, 1999. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Disetronic Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1999
Date Received
November 1, 1999
Clearance Type
Special
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 Disetronic Medical Systems

  • K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVIC (May 14, 2010)
  • K070189 — ACCU-CHEK ULTRAFLEX INFUSION SET (February 21, 2007)
  • K063146 — ACCU-CHEK LINKASSIST (November 27, 2006)
  • K060876 — ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACC (June 15, 2006)
  • K042887 — ACCU-CHEK SPIRIT (March 18, 2005)
  • K043000 — MODIFICATION TO D-TRONPLUS (December 1, 2004)
  • K033892 — ULTRAFLEX INFUSION SET (March 9, 2004)
  • K023471 — DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (October 29, 2002)
  • K022831 — MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP (September 11, 2002)
  • K021725 — DISETRONIC D-TRON INSULIN INFUSION PUMP (August 2, 2002)

Other clearances for product code FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • 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)

FDA data resources