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

Capillus, LLC — Predicate Candidate Screening

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

78 daysmedian FDA review time
92 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro,Capillus, LLC2017-01-31780
K162994Capillus302, Capillus312, Capillus352Capillus, LLC2016-11-18220
K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, CapillusCapillus, LLC2016-04-25820
K153618Capillus202Capillus, LLC2016-01-19320
K151516Capillus82Capillus, LLC2015-08-21770
K150578Capillus 272 Office ProCapillus, LLC2015-06-09920
K143199Capillus 272 ProCapillus, LLC2015-01-29840

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