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510(k) K120685

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

K120685 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "ZYNO MEDICAL ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on September 7, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Zyno Medical, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2012
Date Received
March 6, 2012
Clearance Type
Abbreviated
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)
  • K132841 — ZYNO MEDICAL ADMINISTRATION SET (January 23, 2014)
  • K130690 — Z-800 INFUSION SYSTEM (June 12, 2013)
  • 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

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • 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)

FDA data resources