Rex Medical: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Rex Medical” (first 2003, latest 2012), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 119 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 | 2 | 168 |
| 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 5 | 5 |
| DYB | Introducer, Catheter | 3 | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 3 | 3 |
| DTK | Filter, Intravascular, Cardiovascular | 1 | 1 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 1 | 1 |
Review panels
Most recent Rex Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120346 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | MCW | 2012-06-01 | 119 |
| K113103 | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE | PNO | 2012-05-22 | 216 |
| K102043 | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER | MSD | 2010-11-18 | 121 |
| K091029 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) | MCW | 2010-02-18 | 314 |
| K081410 | OPTION VENA CAVA FILTER | DTK | 2009-06-04 | 380 |
| K071422 | 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET | MSD | 2007-08-22 | 92 |
| K051468 | INNER-LOCK INTRODUCER SHEATH | DYB | 2005-08-04 | 62 |
| K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | MCW | 2004-02-26 | 22 |
| K033793 | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM | MCW | 2003-12-16 | 11 |
| K032569 | SHORT INTRODUCER SHEATH | DYB | 2003-09-16 | 27 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rex Medical.
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.
Device clinical trials
An industry sponsor named Rex Medical is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02961894: Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization (Completed, started 2017-06-07)
- NCT02136004: The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System (Completed, started 2014-05)
- NCT01873898: Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial (Completed, started 2013-06)
- NCT00488865: RexMedical- Option* Vena Cava Filter IDE Study (Completed, started 2006-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rex Medical?
FDA lists 13 510(k) clearances under the applicant name “Rex Medical” (first 2003, latest 2012), across 5 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 Rex Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rex Medical is 119 days.
Which FDA product codes appear under Rex Medical?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 5); DYB (Introducer, Catheter, 3); MSD (Catheter, Hemodialysis, Implanted, 3).
Next steps
- See all 13 Rex Medical clearances with predicates and recalls
- Run predicate analysis for product code MCW, Rex Medical'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.