Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vivant Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
384 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050223 | VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER | Vivant Medical, Inc. | 2005-02-24 | 24 | 0 |
| K040279 | VIVARING MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2004-03-02 | 26 | 0 |
| K032702 | VIVATIP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-10-03 | 31 | 0 |
| K032047 | TRI-LOOP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-08-06 | 35 | 0 |
| K031556 | VIVATHERM THEMPERATURE MEASUREMENT SYSTEM | Vivant Medical, Inc. | 2003-06-23 | 35 | 0 |
| K023311 | LOOP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-04-09 | 188 | 0 |
| K022286 | ENCIRCLE LOCALIZATION DEVICE | Vivant Medical, Inc. | 2002-10-11 | 88 | 0 |
| K011676 | VIVAWAVE MICROWAVE SYSTEM | Vivant Medical, Inc. | 2002-06-18 | 384 | 1 |
| K003439 | VIVANT BREAST LESION LOCALIZATION DEVICE | Vivant Medical, Inc. | 2000-12-15 | 39 | 0 |
| K000278 | VIVANT MEDICAL BIOPSY MARKER SYSTEM | Vivant Medical, Inc. | 2000-06-23 | 144 | 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