Rubicor Medical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Rubicor Medical, Inc.” (first 2002, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 25 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| KNW | Instrument, Biopsy | 2 | 2 |
Review panels
Most recent Rubicor Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071048 | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 | KNW | 2007-05-15 | 32 |
| K070275 | FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE | GEI | 2007-03-09 | 39 |
| K053151 | RUBICOR MAGIC BREAST BIOPSY DEVICE | KNW | 2005-11-18 | 8 |
| K052506 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 | GEI | 2005-10-06 | 23 |
| K032584 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 | GEI | 2003-09-17 | 27 |
| K030049 | MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | GEI | 2003-01-29 | 23 |
| K023601 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | GEI | 2002-11-19 | 22 |
| K020047 | RUBICOR BREAST BIOPSY DEVICE | GEI | 2002-04-05 | 88 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-02-17.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rubicor Medical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Rubicor Medical, Inc.” (first 2002, latest 2007), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rubicor Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rubicor Medical, Inc. is 25 days.
Which FDA product codes appear under Rubicor Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); KNW (Instrument, Biopsy, 2).
Next steps
- See all 8 Rubicor Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Rubicor 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, 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.