Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rubicor Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
88 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071048 | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 | Rubicor Medical, Inc. | 2007-05-15 | 32 | 0 |
| K070275 | FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE | Rubicor Medical, Inc. | 2007-03-09 | 39 | 0 |
| K053151 | RUBICOR MAGIC BREAST BIOPSY DEVICE | Rubicor Medical, Inc. | 2005-11-18 | 8 | 0 |
| K052506 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 | Rubicor Medical, Inc. | 2005-10-06 | 23 | 1 |
| K032584 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 | Rubicor Medical, Inc. | 2003-09-17 | 27 | 1 |
| K030049 | MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODE | Rubicor Medical, Inc. | 2003-01-29 | 23 | 1 |
| K023601 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | Rubicor Medical, Inc. | 2002-11-19 | 22 | 1 |
| K020047 | RUBICOR BREAST BIOPSY DEVICE | Rubicor Medical, Inc. | 2002-04-05 | 88 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda