Atlas FDA

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

Khn Solutions, LLC — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090067BACTRACK SELECT BREATHALYZER, MODEL S80Khn Solutions, LLC2009-03-24740
K083801BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70Khn Solutions, LLC2009-03-19870
K071067BACTRACK LCD ALCOHOL DETECTORKhn Solutions, LLC2007-09-141510
K041334ALCOMATE, MODEL CA2000Khn Solutions, LLC2004-08-11840

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