Horizon Medical Products, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Horizon Medical Products, Inc.” (first 1994, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 12 | 12 |
| MSD | Catheter, Hemodialysis, Implanted | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Review panels
Most recent Horizon Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033473 | MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT | LJT | 2003-11-18 | 15 |
| K032754 | VORTEX MP | LJT | 2003-09-12 | 7 |
| K032557 | TRIUMPH VTX WITH LIFEVALVE CATHETER | LJT | 2003-09-09 | 21 |
| K031718 | LIFEVALVE CENTRAL VENOUS CATHTER | LJS | 2003-07-02 | 29 |
| K022905 | LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER | MSD | 2002-12-13 | 101 |
| K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | 2002-03-29 | 128 |
| K011916 | SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES | MSD | 2001-10-31 | 133 |
| K010767 | LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES | LJT | 2001-04-10 | 27 |
| K010189 | VORTEX ACCESS SYSTEM | LJT | 2001-02-12 | 21 |
| K994196 | HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM | LJT | 2000-02-10 | 59 |
6 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2004-09-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Horizon Diagnostics, Inc. (7 510(k)s)
- Horizon Medical, Inc. (3 510(k)s)
- Horizon Chemical Co. (1 510(k)s)
- Horizon Surgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Horizon Medical Products, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Horizon Medical Products, Inc.” (first 1994, latest 2003), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Horizon Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Horizon Medical Products, Inc. is 114 days.
Which FDA product codes appear under Horizon Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 12); MSD (Catheter, Hemodialysis, Implanted, 2); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 16 Horizon Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Horizon Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.