I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K040337 ↗

FDA Product Code

MEB

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Soaker Catheter

  Class II

  FDA 510(k) K994374 Active Cleared 3 Mar 2000

• Painbuster Infusion Kit

  Class II

  FDA 510(k) K982946 Active Cleared 18 Nov 1998

• Titan Driver 60cc, 30 Minute Administration Set

  Class II

  FDA 510(k) K953028 Active Cleared 28 Sep 1995

• Paragon Infusion System

  Class II

  FDA 510(k) K020251 Active Cleared 15 Feb 2002

• Sidekick Infusion Kit

  Class II

  FDA 510(k) K990425 Active Cleared 23 Apr 1999

• I-Flow Elastomeric Pump with Bolus

  Class II

  FDA 510(k) K023318 Active Cleared 18 Oct 2002

See all devices from I-Flow Corp. →