Ideas For Medicine, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Ideas For Medicine, Inc.” (first 1980, latest 1997), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | 4 | 4 |
| DQT | Occluder, Catheter Tip | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| MJN | Catheter, Intravascular Occluding, Temporary | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
Review panels
- Cardiovascular (12)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Ideas For Medicine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961883 | VERSA-CATH ARTERIAL CATHETER | DXE | 1997-01-13 | 243 |
| K962751 | IDEAS' DUAL PORT | LJT | 1996-09-30 | 77 |
| K961716 | VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE | DXE | 1996-09-19 | 140 |
| K960715 | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F | MJN | 1996-09-09 | 201 |
| K960422 | PRUITT SAFETY OCCLUSION CATHETER | MJN | 1996-08-07 | 191 |
| K954713 | DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) | FGE | 1996-07-24 | 288 |
| K935964 | IDEAS OCCLUDER | DXC | 1995-01-04 | 387 |
| K935023 | GODAT UTERINE MANIPULATOR INJECTOR | LKF | 1995-01-04 | 441 |
| K880231 | MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER | DQT | 1988-05-25 | 133 |
| K872090 | THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT | DQT | 1987-10-30 | 151 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ideas For Medicine, Inc..
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.
- Ideas For Living (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ideas For Medicine, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Ideas For Medicine, Inc.” (first 1980, latest 1997), across 8 product codes in 4 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 Ideas For Medicine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ideas For Medicine, Inc. is 140 days.
Which FDA product codes appear under Ideas For Medicine, Inc.?
The most frequent FDA product codes under this applicant name are DXE (Catheter, Embolectomy, 4); DQT (Occluder, Catheter Tip, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2).
Next steps
- See all 15 Ideas For Medicine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXE, Ideas For Medicine, 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.