Atlas FDA

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

Scientific Research — Predicate Candidate Screening

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

115 daysmedian FDA review time
319 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912420ORTHOFIX UNREAMED TIBIAL NAIL SYSTEMScientific Research1991-09-231150
K843077ELISA FOR HERPES SIMPLEX VIRUSScientific Research1985-06-213190
K842887HERPES VIRUS AGGLUTINATION TESTScientific Research1985-02-262180
K843369AGGLUTINATION TEST FOR TOTAL IGEScientific Research1984-11-14780
K843710ELISA FOR TOTAL IGEScientific Research1984-10-22310

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