# Clarus Medical, LLC

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 10 (2001–2026): 10 510(k) clearances
- Product codes: HRX (4), GEX (3), GWG (2), BTR (1)
- 510(k) review time since 2016: median 306 days, against 164 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 31 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgical Dynamics, Inc.: 6 (https://510kreport.com/company/surgical-dynamics)
- Clarus Medical Systems, Inc.: 6 (https://510kreport.com/company/clarus-medical-systems)
- Laser Peripherals, LLC: 6 (https://510kreport.com/company/laser-peripherals)
- Trimedyne, Inc.: 2 (https://510kreport.com/company/trimedyne)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)
- Medical Instrument Development Laboratories, Inc.: 1 (https://510kreport.com/company/medical-instrument-development-laboratories)
- Medtronic PS Medical: 1 (https://510kreport.com/company/medtronic-ps-medical)
- Vision-Sciences, Inc.: 1 (https://510kreport.com/company/vision-sciences)

## Firms that cite its devices most
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- X-Sten Corp.: 1 (https://510kreport.com/company/x-sten)
- Corespine Technologies, LLC: 1 (https://510kreport.com/company/corespine-technologies)
- Blazejewski Medi-Tech GmbH: 1 (https://510kreport.com/company/blazejewski-medi-tech)

## Its most-cited devices
- K040919: Nucleotome Probe Set, Model 21200 (2004), cited by 3
- K011454: Spine Scope, Model 2180 (2001), cited by 3
- K022610: Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 (2002), cited by 1
- K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120 (2004), cited by 1

## Recent decisions
- K252790: Digital ClarusScope System and Digital NeuroPEN System (May 26, 2026)
- K240535: Digital ClarusScope System; Digital NeuroPEN System (Apr 25, 2024)
- K223615: Digital ClarusScope System, Digital NeuroPEN System (Nov 21, 2023)
- K200925: Clarus Peel-Away Introducer Sheath (Mar 18, 2021)
- K082038: Clarus Video Airway Endoscope, Models 30000-V and 30003-V (Apr 28, 2009)
- K040919: Nucleotome Probe Set, Model 21200 (Jun 1, 2004)
- K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120 (May 11, 2004)
- K022610: Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 (Nov 5, 2002)

Source page: https://510kreport.com/company/clarus-medical