Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sanarus Medical, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
98 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080171 | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, | Sanarus Medical, Inc. | 2008-03-06 | 42 | 0 |
| K073533 | SANARUS V2 TREATMENT SYSTEM | Sanarus Medical, Inc. | 2008-02-07 | 52 | 0 |
| K062896 | V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MO | Sanarus Medical, Inc. | 2007-01-03 | 98 | 0 |
| K061510 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2006-07-18 | 47 | 0 |
| K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2 | Sanarus Medical, Inc. | 2005-11-15 | 35 | 0 |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | Sanarus Medical, Inc. | 2005-07-27 | 42 | 0 |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2004-09-08 | 30 | 0 |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2003-10-09 | 56 | 0 |
| K020054 | SANARUS INDICA MARKER SYSTEM | Sanarus Medical, Inc. | 2002-10-16 | 281 | 0 |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-10-15 | 90 | 1 |
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | Sanarus Medical, Inc. | 2002-09-23 | 24 | 1 |
| K021137 | SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2002-06-26 | 78 | 0 |
| K021211 | MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-06-26 | 70 | 0 |
| K020605 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | 2002-03-08 | 11 | 0 |
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