510(k) Report

FDA applicant

Vortex Medical, Inc.

Norwell, MA3 decisions2009–20141 recall

FDA records 3 decisions for Vortex Medical, Inc. (Norwell, MA) from 2009 to 2014: 3 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DWE (Tubing, Pump, Cardiopulmonary Bypass). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 recall is 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 Vortex Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 22014: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Vortex Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DWETubing, Pump, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K091304Vortex CannulaVortex Medical, Inc. · 20091cites it
  • K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 20091cites it
  • K133445Angiovac CannulaVortex Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K133445Angiovac CannulaVortex Medical, Inc. · 2014
  • K092486Vortex Medical Angiovac Cardiopulmonary Bypass CircuitVortex Medical, Inc. · 20091 recall
  • K091304Vortex CannulaVortex Medical, Inc. · 2009

All 3 as Vortex Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092486Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only --…Mar 21, 2016Class II

Other applicant names beginning “Vortex”

FDA records each applicant name separately; these may or may not be the same firm.

Vortex Surgical, Inc. 2