Therex Corp.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Therex Corp.” (first 1988, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 | 24 | 24 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (26)
Most recent Therex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953110 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | LJT | 1995-09-13 | 72 |
| K953017 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | LJT | 1995-09-08 | 71 |
| K952537 | THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. | LJT | 1995-07-06 | 36 |
| K950212 | A2 DETACHED DUAL PORT SYSTEM | LJT | 1995-04-13 | 84 |
| K950131 | 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL | LJT | 1995-03-23 | 69 |
| K942412 | THEREX LOW-PROFILE PORT - TITANIUM MODEL | LJT | 1994-08-19 | 91 |
| K936012 | THEREX LOW PROFILE PORT-TITANIUM MODEL | LJT | 1994-03-22 | 96 |
| K934802 | THEREX LOW-PROFILE PORT-TITANIUM | LJT | 1994-03-22 | 166 |
| K934792 | THEREX LOW-PROFILE PORT | LJT | 1994-03-22 | 167 |
| K933350 | THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM | LJT | 1994-02-23 | 229 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Therex Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Therex Corp.?
FDA lists 26 510(k) clearances under the applicant name “Therex Corp.” (first 1988, latest 1995), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Therex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Therex Corp. is 92 days.
Which FDA product codes appear under Therex Corp.?
The most frequent FDA product codes under this applicant name are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 24); FMI (Needle, Hypodermic, Single Lumen, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 26 Therex Corp. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Therex Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.