Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Horizons Intl. Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
183 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | Horizons Intl. Corp. | 2008-12-23 | 70 | 0 |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | Horizons Intl. Corp. | 2002-10-25 | 102 | 0 |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | Horizons Intl. Corp. | 2002-10-25 | 105 | 0 |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | Horizons Intl. Corp. | 2002-08-12 | 11 | 0 |
| K021998 | HORIZONS CYTOLOGY BRUSH | Horizons Intl. Corp. | 2002-07-12 | 23 | 0 |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | Horizons Intl. Corp. | 2002-06-21 | 29 | 0 |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | Horizons Intl. Corp. | 2001-08-16 | 78 | 0 |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | Horizons Intl. Corp. | 2001-05-16 | 90 | 0 |
| K002236 | HORIZONS PAPILLOTOME | Horizons Intl. Corp. | 2001-01-23 | 183 | 0 |
| K002235 | HORIZONS ERCP CANNULA | Horizons Intl. Corp. | 2001-01-23 | 183 | 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