Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Horizons Diagnostics Co. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
756 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932622 | CHOLERA SMART(TM) | New Horizons Diagnostics Co. | 1995-06-27 | 756 | 0 |
| K925190 | PYLORISCREEN | New Horizons Diagnostics Co. | 1993-03-23 | 160 | 0 |
| K922432 | CHOLERASCREEN | New Horizons Diagnostics Co. | 1992-12-07 | 199 | 0 |
| K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | New Horizons Diagnostics Co. | 1988-02-19 | 92 | 0 |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | New Horizons Diagnostics Co. | 1987-05-28 | 62 | 0 |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | New Horizons Diagnostics Co. | 1987-05-13 | 55 | 0 |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | New Horizons Diagnostics Co. | 1986-06-30 | 21 | 0 |
| K851132 | LATEX AGGLUTINATION TEST | New Horizons Diagnostics Co. | 1985-07-05 | 106 | 0 |
| K821362 | IMPROVED GONO GEN | New Horizons Diagnostics Co. | 1982-08-04 | 89 | 0 |
| K820007 | NEISSERIA GONORRHOEAE TEST | New Horizons Diagnostics Co. | 1982-01-29 | 25 | 0 |
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