Home / 510(k) Clearances / K172653

510(k) K172653

Power Infuser by ZOLL Medical Corporation — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2018
Date Received
September 5, 2017
Clearance Type
Traditional
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 ZOLL Medical Corporation

  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K202375 — ZOLL Propaq M (March 9, 2021)
  • K180482 — ZOLL Propaq M (November 30, 2018)
  • K162832 — 731 Series Ventilators (August 2, 2017)
  • K170533 — Model 330 Multifunction Aspirator (April 18, 2017)
  • K142915 — ZOLL X Series (December 3, 2014)
  • K141774 — ZOLL X SERIES (November 19, 2014)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K132488 — ZOLL CODE WRITER (April 3, 2014)
  • K131919 — ZOLL EPCR IOS (December 17, 2013)

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)