Home / 510(k) Clearances / K131249

510(k) K131249

ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES by I-Flow, LLC — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2014
Date Received
May 1, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by I-Flow, LLC

  • 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)
  • K022869 — SOAKER CATHETER (September 20, 2002)

Other clearances for product code MEB

  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)
  • K072053 — SMARTBLOCK PAIN PUMP (November 6, 2007)