Atlas FDA

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

Brahms Diagnostica, LLC · Predicate Candidate Screening

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

85 daysmedian FDA review time
169 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033454BRAHMS DIAGNOSTICA LUMITEST TRAK HUMANBrahms Diagnostica, LLC2004-03-221440
K021057BRAHMS DIAGNOSTICA DYNOTEST TG-PLUSBrahms Diagnostica, LLC2002-09-171690
K000287BRAHMS DIAGNOSTICA LUMITEST ANTI-TPOBrahms Diagnostica, LLC2000-03-17460
K000286BRAHMS DIAGNOSTICA LUMITEST ANTI-TGBrahms Diagnostica, LLC2000-03-17460
K992791BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPOBrahms Diagnostica, LLC1999-11-12850
K992790BRAHMS DIAGNOSTICA DYNOTEST ANTI-TGBrahms Diagnostica, LLC1999-11-12850

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