510(k) Report

FDA applicant

Clarus Medical, LLC

Minneapolis, MN10 decisions2001–20262 recalls

FDA records 10 decisions for Clarus Medical, LLC (Minneapolis, MN) from 2001 to 2026: 10 510(k) clearances. Most are in product codes HRX (Arthroscope) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 306 days from receipt to decision, against 164 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 4 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2024

2009: 12021: 12023: 12024: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2010: 12021: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Clarus Medical, LLC’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?

  • HRXArthroscope4decisions
  • GEXPowered Laser Surgical Instrument3decisions
  • GWGEndoscope, Neurological2decisions
  • BTRTube, Tracheal (W/Wo Connector)1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 306 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 164 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 20043cite it
  • K011454Spine Scope, Model 2180Clarus Medical, LLC · 20013cite it
  • K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Clarus Medical, LLC · 20021cites it
  • K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120Clarus Medical, LLC · 20041cites it

What has FDA decided for it lately?

  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026
  • K240535Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC · 2024
  • K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC · 2023
  • K200925Clarus Peel-Away Introducer SheathClarus Medical, LLC · 2021
  • K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009
  • K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 20041 recall
  • K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120Clarus Medical, LLC · 20041 recall
  • K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Clarus Medical, LLC · 2002

All 10 as Clarus Medical, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K040424Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device…Jul 27, 2021Class II
  • K040919i-STAT EC8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro…Feb 5, 2010

Other applicant names beginning “Clarus”

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

Clarus Medical Systems, Inc. 22Clarus Viewer Corporation 1