Home / 510(k) Clearances / K132841

510(k) K132841

ZYNO MEDICAL ADMINISTRATION SET by Zyno Medical, LLC — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2014
Date Received
September 10, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Zyno Medical, LLC

  • K153193 — Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory I (August 30, 2016)
  • K140783 — HALO AMBULATORY INFUSION SYSTEM (October 17, 2014)
  • K130690 — Z-800 INFUSION SYSTEM (June 12, 2013)
  • K120685 — ZYNO MEDICAL ADMINISTRATION SET (September 7, 2012)
  • K100705 — ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (July 8, 2010)
  • K071545 — Z-800 VOLUMETRIC INFUSION PUMP (October 31, 2007)

Other clearances for product code FPA

  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)