Rex Medical, L.P.: FDA clearances and approvals
Rex Medical, L.P. has 8 FDA 510(k) clearances (first 2004, latest 2021), plus 1 PMA decision, across 6 product codes in 2 review panels. Median 510(k) review time: 106 days. Since 2017 its median was 107 days, against 73 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 56 |
| 2014 | 1 | 150 |
| 2015 | 1 | 139 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 92 |
| 2019 | 1 | 107 |
| 2020 | 0 | — |
| 2021 | 1 | 139 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Rex Medical, L.P.'s cleared 510(k)s took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 73 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 3 | 3 |
| DTK | Filter, Intravascular, Cardiovascular | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| MGB | Device, Hemostasis, Vascular | 1 | 0 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Review panels
Most recent Rex Medical, L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212351 | Revolution Peripheral Atherectomy System | MCW | 2021-12-15 | 139 |
| K191419 | Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire | MCW | 2019-09-12 | 107 |
| K173389 | Rex Medical Aspiration Pump | BTA | 2018-01-30 | 92 |
| K143405 | Option (TM) ELITE Vena Cava Filter 100cm System | DTK | 2015-04-16 | 139 |
| K141617 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | QEW | 2014-11-14 | 150 |
| K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM | DTK | 2013-12-17 | 56 |
| K060904 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | MCW | 2006-04-28 | 25 |
| K042399 | MODIFICATION TO SHORT INTRODUCER SHEATH | DYB | 2004-12-17 | 105 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150022 | PMA | CLOSER VASCULAR SEALING SYSTEM | 2016-02-12 |
Recalls
openFDA lists no recalls under a recalling firm named Rex Medical, L.P..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Rex Medical, L.P. have?
Rex Medical, L.P. has 8 FDA 510(k) clearances (first 2004, latest 2021), plus 1 PMA decision, across 6 product codes in 2 review panels.
How long does FDA take to clear Rex Medical, L.P.'s 510(k)s?
The median time from FDA receipt to decision across Rex Medical, L.P.'s cleared 510(k)s is 106 days. Since 2017: 107 days, versus 73 days for all cleared 510(k)s in the same product codes.
What devices does Rex Medical, L.P. make?
Its most frequent FDA product codes are MCW (Catheter, Peripheral, Atherectomy, 3); DTK (Filter, Intravascular, Cardiovascular, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Has Rex Medical, L.P. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rex Medical, L.P. Related entities may recall under other names.
Next steps
- See all 8 Rex Medical, L.P. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Rex Medical, L.P.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.