510(k) Report

FDA applicant

Flowmedica, Inc.

Fremont, CA3 decisions2004–20086 recalls

FDA records 3 decisions for Flowmedica, Inc. (Fremont, CA) from 2004 to 2008: 3 510(k) clearances. All are in product code KRA (Catheter, Continuous Flush). Its devices cite 10 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Flowmedica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

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

2026 so far, outlined.

Recalls per year

3in 2012

2010: 22011: 12012: 3
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Flowmedica, Inc.’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?

  • KRACatheter, Continuous Flush3decisions

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050205Benephit Bifurcated Infusion Catheter and 5FR. Introducer SheathFlowmedica, Inc. · 20051cites it
  • K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc. · 20041cites it

What has FDA decided for it lately?

  • K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc. · 20086 recalls
  • K050205Benephit Bifurcated Infusion Catheter and 5FR. Introducer SheathFlowmedica, Inc. · 20052 recalls
  • K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc. · 20042 recalls

All 3 as Flowmedica, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K082163AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…Feb 6, 2012
  • K082163AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…Feb 6, 2012
  • K082163AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…Feb 6, 2012
  • K082163Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035…Dec 5, 2011
  • K033569ANGIODYNAMICS BENEPHIT (TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion…Apr 30, 2010
  • K033569ANGIODYNAMICS BENEPHIT (TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion…Apr 30, 2010