FDA applicant

Innovision A/S

Lake Bluff, IL4 decisions2006–20111 recall

FDA records 4 decisions for Innovision A/S (Lake Bluff, IL) from 2006 to 2011: 4 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and BZC (Calculator, Pulmonary Function Data). Its devices cite 17 predicates, 6 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, anesthesiology panel, where it files most

How often FDA has decided Innovision A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Innovision A/S’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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Other applicant names beginning “Innovision”

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

Innovision, Inc. 6 Innovision Medical, Inc. 2 Innovision Medical Technologies, LLC 1

Innovision A/S

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Innovision”