FDA applicant

Clarus Medical Systems, Inc.

Minneapolis, MN22 decisions1992–19982 recalls

FDA records 22 decisions for Clarus Medical Systems, Inc. (Minneapolis, MN) from 1992 to 1998: 22 510(k) clearances. Most are in product codes GWG (Endoscope, Neurological) and HRX (Arthroscope). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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 Clarus Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clarus Medical Systems, Inc. since 2007.

Recalls per year

1in 2021

2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Clarus Medical Systems, 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

Other applicant names beginning “Clarus”

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

Clarus Medical, LLC 10 Clarus Viewer Corporation 1

Clarus Medical Systems, 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 “Clarus”