Clarus Medical, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Clarus Medical, LLC” (first 2001, latest 2026), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 306 days, against 94 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 345 |
| 2022 | 0 | — |
| 2023 | 1 | 351 |
| 2024 | 1 | 59 |
| 2025 | 0 | — |
| 2026 | 1 | 266 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clarus Medical, LLC took a median 306 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| GWG | Endoscope, Neurological | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
Review panels
- Orthopedic (4)
- General and Plastic Surgery (3)
- Neurology (2)
- Anesthesiology (1)
Most recent Clarus Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | HRX | 2026-05-26 | 266 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | HRX | 2024-04-25 | 59 |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | GWG | 2023-11-21 | 351 |
| K200925 | Clarus Peel-Away Introducer Sheath | GWG | 2021-03-18 | 345 |
| K082038 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V | BTR | 2009-04-28 | 285 |
| K040919 | NUCLEOTOME PROBE SET, MODEL 21200 | HRX | 2004-06-01 | 54 |
| K040424 | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 | GEX | 2004-05-11 | 83 |
| K022610 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 | GEX | 2002-11-05 | 91 |
| K021848 | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 | GEX | 2002-09-03 | 90 |
| K011454 | SPINE SCOPE, MODEL 2180 | HRX | 2001-12-13 | 216 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-07-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Clarus Medical Systems, Inc. (22 510(k)s)
- Clarus Viewer Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clarus Medical, LLC?
FDA lists 10 510(k) clearances under the applicant name “Clarus Medical, LLC” (first 2001, latest 2026), across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clarus Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clarus Medical, LLC is 154 days. Since 2017: 306 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clarus Medical, LLC?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 4); GEX (Powered Laser Surgical Instrument, 3); GWG (Endoscope, Neurological, 2).
Next steps
- See all 10 Clarus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRX, Clarus Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.