FDA applicant

Optical Sensors, Inc.

Eden Prairie, MN7 decisions1993–20041 recall

FDA records 7 decisions for Optical Sensors, Inc. (Eden Prairie, MN) from 1993 to 2004: 7 510(k) clearances. Most are in product codes CCC (Analyzer, Gas, Carbon-Dioxide, Partial…) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 6 predicates, 4 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 Optical Sensors, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optical Sensors, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optical Sensors, 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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Other applicant names beginning “Optical”

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

Optical Micro Systems, Inc. 21 Optical Radiation Corp. 3 Optical Imaging, Ltd. 2 Optical Integrity, Inc. 2 Optical Connection, Inc. 2 Optical Systems Intl., Inc. 2 Optical Polymer Research, Inc. 2 Optical Diagnostics, Inc. 1 Optical Center 1 Optical Moulding Systems 1 Optical Xpressions, Ltd. 1 Optical Coating Laboratory, Inc. 1

Optical Sensors, Inc.

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 “Optical”