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510(k) K163400

Orbit Inserter by Ypsomed AG — Product Code KZH

K163400 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "Orbit Inserter". The FDA issued a decision of Substantially Equivalent on July 26, 2017. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Ypsomed AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2017
Date Received
December 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

Other clearances by Ypsomed AG

  • K243901 — SmartPilot YpsoMate NS-A2.25 (August 28, 2025)
  • K171984 — Clickfine Pen Needle, Penfine Classic Pen Needle (October 11, 2017)
  • K150921 — Orbit Infusion Set (April 12, 2016)
  • K152514 — Clickfine AutoProtect Pen Needle (November 18, 2015)
  • K150662 — Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (June 9, 2015)
  • K131123 — CLICKFINE AUTOPROTECT PEN NEEDLE (July 5, 2013)
  • K131125 — CLICKFINE PEN NEEDLE (July 5, 2013)
  • K130468 — ORBIT INFUSION SET (March 19, 2013)
  • K110312 — CLICKFINE AUTOPROTECT PEN NEEDLE (January 26, 2012)
  • K102108 — CLICKFINE PEN NEEDLE (November 23, 2010)

Other clearances for product code KZH

  • K243232 — GripMate (December 2, 2024)
  • K213429 — AccuSert Needle Inserter (October 20, 2022)
  • K160860 — MiniMed Quick-serter (September 22, 2016)
  • K141384 — WHISPERJECT AUTOINJECTOR (September 12, 2014)
  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2) (October 2, 2008)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)
  • K062339 — DERMOTHERAP GUN (February 5, 2007)

FDA data resources