510(k) Report

FDA applicant

I-Flow Corp.

Lake Forest, CA42 decisions1988–201410 recalls

FDA records 42 decisions for I-Flow Corp. (Lake Forest, CA) from 1988 to 2014: 42 510(k) clearances. Most are in product codes MEB (Pump, Infusion, Elastomeric) and FRN (Pump, Infusion). Its devices cite 70 predicates, 40 of them its own earlier devices. 10 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “I-Flow, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided I-Flow Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2012

2008: 32011: 12012: 1, 1 Class I
2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — I-Flow Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like I-Flow Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MEBPump, Infusion, Elastomeric17decisions
  • FRNPump, Infusion13decisions
  • FPASet, Administration, Intravascular9decisions
  • BSOCatheter, Conduction, Anesthetic3decisions

Whose devices does it build on?

Its devices cite 70 predicates; 40 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 84 times; 40 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K980558Painbuster Infusion SystemI-Flow Corp. · 19987cite it
  • K982946Painbuster Infusion KitI-Flow Corp. · 19987cite it
  • K040337I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 20046cite it
  • K994374Soaker CatheterI-Flow Corp. · 20006cite it
  • K923875Sidekick 50 Plus and Sidekick 100 PlusI-Flow Corp. · 19936cite it
  • K991543Intraop CatheterI-Flow Corp. · 19995cite it

What has FDA decided for it lately?

  • K131249ON-Q Painbuster, on-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesI-Flow, LLC · 2014
  • K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, EasypumpI-Flow Corp. · 20073 recalls
  • K063234ON-Q IntroducersI-Flow Corp. · 2006
  • K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005
  • K052117I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)I-Flow Corp. · 20053 recalls
  • K043456Modification to Soaker CatheterI-Flow Corp. · 2005
  • K040337I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 2004
  • K023883Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, KvoI-Flow Corp. · 2002

All 41 as I-Flow Corp. →The one decision as I-Flow, LLC →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K023318ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select…May 8, 2012Class I
  • K063530I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent…Apr 15, 2011
  • K063530On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated…Feb 14, 2008
  • K063530ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump…Feb 12, 2008
  • K052117I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in…Feb 11, 2008
  • K052117Easypump ST 100-1 infusion pumpJan 17, 2006