510(k) Report

FDA applicant

Vycor Medical, Inc.

Boca Raton, FL2 decisions2006–20211 recall

FDA records 2 decisions for Vycor Medical, Inc. (Boca Raton, FL) from 2006 to 2021: 2 510(k) clearances. All are in product code GZT (Retractor, Self-Retaining, For Neurosurgery). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Vycor Medical, LLC”.

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

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

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

FDA decisions per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1, 1 Class I
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Vycor Medical, 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?

  • GZTRetractor, Self-Retaining, For Neurosurgery2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K060973Vycor Surgical Access SystemsVycor Medical, LLC · 20062cite it

What has FDA decided for it lately?

  • K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the…Vycor Medical, Inc. · 2021
  • K060973Vycor Surgical Access SystemsVycor Medical, LLC · 20061 Class I recall

The one decision as Vycor Medical, Inc. →The one decision as Vycor Medical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060973Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product…Aug 21, 2012Class I