Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Clarus Medical, LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

216 daysmedian FDA review time
351 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC2026-05-262660
K240535Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC2024-04-25590
K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC2023-11-213510
K200925Clarus Peel-Away Introducer SheathClarus Medical, LLC2021-03-183450
K082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VClarus Medical, LLC2009-04-282850
K040919NUCLEOTOME PROBE SET, MODEL 21200Clarus Medical, LLC2004-06-01541
K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANClarus Medical, LLC2004-05-11830
K022610CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE Clarus Medical, LLC2002-11-05910
K021848CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASERClarus Medical, LLC2002-09-03900
K011454SPINE SCOPE, MODEL 2180Clarus Medical, LLC2001-12-132160

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda