Home / 510(k) Clearances / K140783

510(k) K140783

HALO AMBULATORY INFUSION SYSTEM by Zyno Medical, LLC — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
March 31, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
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)
  • K132841 — ZYNO MEDICAL ADMINISTRATION SET (January 23, 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 FRN

  • K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubin (January 28, 2026)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K242752 — MRidium 3870 MRI Infusion Pump System (3870) (May 28, 2025)
  • K243855 — BD Alaris Infusion System with Guardrails Suite MX (April 25, 2025)
  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Inf (December 23, 2024)