Atlas FDA

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

Horizon Diagnostics, Inc. — Predicate Candidate Screening

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

140 daysmedian FDA review time
1046 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971566CREATINE KINASE-MB REAGENT SETHorizon Diagnostics, Inc.1997-07-14760
K933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTHorizon Diagnostics, Inc.1996-06-1310460
K935712IRON/TIBC REAGENTHorizon Diagnostics, Inc.1995-09-206590
K930678AMYLASEHorizon Diagnostics, Inc.1994-04-064210
K934533BUN-300/BUN-500 UREA NITROGEN REAGENTHorizon Diagnostics, Inc.1993-11-26700
K930679DIRECT BILIRUBINHorizon Diagnostics, Inc.1993-06-291400
K930074IN-VITRO DIAGNOSTIC REAGENT SETHorizon Diagnostics, Inc.1993-05-111240

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