Med Institute, Inc.: FDA clearances and approvals
Med Institute, Inc. has 26 FDA 510(k) clearances (first 1990, latest 2000), across 8 product codes in 5 review panels. Median 510(k) review time: 96 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 | 17 | 17 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | 2 |
| GCC | Dilator, Catheter | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MQR | Stent, Colonic, Metallic, Expandable | 1 | 1 |
Review panels
- General Hospital (18)
- Cardiovascular (3)
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
- Radiology (1)
Most recent Med Institute, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990034 | WILSON-COOK COLONIC Z-STENT | MQR | 2000-04-17 | 467 |
| K982507 | MINI POLYURETHANE CATHETER | LJT | 1998-09-16 | 58 |
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | GCC | 1998-05-26 | 64 |
| K964001 | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | ITX | 1998-04-17 | 557 |
| K971140 | VITAL-PORT INFUSION PAL | LJT | 1997-11-17 | 234 |
| K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | LJT | 1997-04-30 | 84 |
| K945586 | FLEXIBLE DILATING SHEATH | DRE | 1997-04-04 | 872 |
| K960698 | NON-CORING NEEDLE | FMI | 1996-04-15 | 55 |
| K941228 | ENDOLUMINAL ACCESS TUBE | KNT | 1995-09-27 | 561 |
| K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM | LJT | 1995-07-31 | 144 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med Institute, Inc..
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.
Device clinical trials
Med Institute, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05883943: Cook Venous Valve System for Treatment of Chronic Venous Insufficiency (Active not recruiting, started 2023-04-24)
Frequently asked questions
How many FDA 510(k) clearances does Med Institute, Inc. have?
Med Institute, Inc. has 26 FDA 510(k) clearances (first 1990, latest 2000), across 8 product codes in 5 review panels.
How long does FDA take to clear Med Institute, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Med Institute, Inc.'s cleared 510(k)s is 96 days.
What devices does Med Institute, Inc. make?
Its most frequent FDA product codes are LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 17); DRE (Dilator, Vessel, For Percutaneous Catheterization, 2); GCC (Dilator, Catheter, 2).
Has Med Institute, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Med Institute, Inc. Related entities may recall under other names.
Next steps
- See all 26 Med Institute, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJT, Med Institute, Inc.'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.