Research Medical, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Research Medical, Inc.” (first 1984, latest 1997), across 15 product codes in 7 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 15 | 15 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQR | Cannula, Catheter | 2 | 2 |
| DXC | Clamp, Vascular | 2 | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| DSS | Clip, Vascular | 1 | 1 |
| FQH | Lavage, Jet | 1 | 1 |
| GBW | Catheter, Peritoneal | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (26)
- Gastroenterology and Urology (3)
- General Hospital (2)
- Anesthesiology (1)
- Immunology (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Research Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | KDI | 1997-07-08 | 130 |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | KYZ | 1997-02-19 | 79 |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | DWF | 1996-08-13 | 88 |
| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | DQR | 1996-03-26 | 75 |
| K951344 | RMI HEMOCONCENTRATOR | KDI | 1995-08-15 | 144 |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | FQH | 1993-01-29 | 270 |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | DXC | 1992-12-18 | 294 |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | MJN | 1992-12-08 | 343 |
| K920676 | RMI SOFCLAMP | DSS | 1992-04-15 | 61 |
| K910221 | RMI VASCULAR TOURNIQUET KIT | DXC | 1991-05-16 | 119 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Research Medical, 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.
- Research Instruments , Ltd. (9 510(k)s)
- Research Development Corp. (6 510(k)s)
- Research Industries Corp. (5 510(k)s)
- Research Diagnostics, Inc. (3 510(k)s)
- Research Consultants, Inc. (1 510(k)s)
- Research Endoscope Systems Intl. (1 510(k)s)
- Research Instrumentation Associates, Inc. (1 510(k)s)
- Research Surgical Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Research Medical, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Research Medical, Inc.” (first 1984, latest 1997), across 15 product codes in 7 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 Research Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Research Medical, Inc. is 90 days.
Which FDA product codes appear under Research Medical, Inc.?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 15); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 3); DQO (Catheter, Intravascular, Diagnostic, 2).
Next steps
- See all 35 Research Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWF, Research Medical, 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 (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.