510(k) Report

FDA applicant

Cardio-Optics, Inc.

Boulder, CO2 decisions2005–20060 recalls

FDA records 2 decisions for Cardio-Optics, Inc. (Boulder, CO) from 2005 to 2006: 2 510(k) clearances. All are in product code LYK (Angioscope). Its devices cite 11 predicates, 1 of them its own earlier devices. No 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Cardio-Optics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardio-Optics, 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?

  • LYKAngioscope2decisions

Whose devices does it build on?

Its devices cite 11 predicates; 1 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.

  • K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
  • K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005

All 2 as Cardio-Optics, Inc. →