Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Horizon Medical Products, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
192 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | Horizon Medical Products, Inc. | 2003-11-18 | 15 | 2 |
| K032754 | VORTEX MP | Horizon Medical Products, Inc. | 2003-09-12 | 7 | 1 |
| K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | Horizon Medical Products, Inc. | 2003-09-09 | 21 | 1 |
| K031718 | LIFEVALVE CENTRAL VENOUS CATHTER | Horizon Medical Products, Inc. | 2003-07-02 | 29 | 0 |
| K022905 | LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER | Horizon Medical Products, Inc. | 2002-12-13 | 101 | 0 |
| K013871 | LIFEGUARD SAFETY INFUSION SET | Horizon Medical Products, Inc. | 2002-03-29 | 128 | 2 |
| K011916 | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 | Horizon Medical Products, Inc. | 2001-10-31 | 133 | 0 |
| K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | Horizon Medical Products, Inc. | 2001-04-10 | 27 | 1 |
| K010189 | VORTEX ACCESS SYSTEM | Horizon Medical Products, Inc. | 2001-02-12 | 21 | 2 |
| K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT | Horizon Medical Products, Inc. | 2000-02-10 | 59 | 0 |
| K951814 | TRIUMPH-1 PORT | Horizon Medical Products, Inc. | 1995-08-29 | 133 | 1 |
| K933986 | HMP POLYSULFONE PORT | Horizon Medical Products, Inc. | 1994-02-25 | 192 | 0 |
| K933990 | HMP TITANIUM PORT | Horizon Medical Products, Inc. | 1994-02-25 | 192 | 0 |
| K934504 | HMP DUAL TITANIUM PORT | Horizon Medical Products, Inc. | 1994-02-25 | 163 | 0 |
| K934573 | HMP TITANIUM LOW PROFILE PORT | Horizon Medical Products, Inc. | 1994-02-25 | 157 | 0 |
| K934640 | HMP DUAL POLYSULFONE PORT | Horizon Medical Products, Inc. | 1994-02-25 | 150 | 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