Atlas FDA

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

Horiba Instruments, Inc. · Predicate Candidate Screening

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

28 daysmedian FDA review time
114 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853405ELECTROLYTE ANALYZER SERA-252Horiba Instruments, Inc.1985-12-041140
K853356SERA-210 ELECTROLYTE ANALYZERHoriba Instruments, Inc.1985-09-03220
K844806MODIFY ELECTROLYTE ANALYZER MODEL SERA-210Horiba Instruments, Inc.1985-01-08280
K841424ELECTROLYTE ANALYZER SERA-210Horiba Instruments, Inc.1984-06-22770
K841441SERA-250Horiba Instruments, Inc.1984-04-0600

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