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510(k) K020251

PARAGON INFUSION SYSTEM by I-Flow Corp. — Product Code FRN

K020251 is an FDA 510(k) premarket notification submitted by I-Flow Corp. for the device "PARAGON INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 15, 2002. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. I-Flow Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2002
Date Received
January 24, 2002
Clearance Type
Special
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 I-Flow Corp.

  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K063530 — ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, (January 26, 2007)
  • K063234 — ON-Q INTRODUCERS (November 21, 2006)
  • K051401 — ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER (November 30, 2005)
  • K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) (September 9, 2005)
  • K043456 — MODIFICATION TO SOAKER CATHETER (January 11, 2005)
  • K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) (May 24, 2004)
  • K023883 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO (December 20, 2002)
  • K023827 — PARAGON INFUSION SYSTEM WITH BOLUS (December 13, 2002)
  • K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS (October 18, 2002)

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)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K242115 — Plum Duo™ 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)

FDA data resources