Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cianna Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
139 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2018-08-02 | 107 | 0 |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2017-10-31 | 139 | 0 |
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | 2016-07-29 | 58 | 0 |
| K141318 | CIANNA MEDICAL SGS SYSTEM | Cianna Medical, Inc. | 2014-08-27 | 99 | 0 |
| K132463 | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM | Cianna Medical, Inc. | 2013-12-03 | 118 | 0 |
| K101411 | SAVI PREPARATION DEVICE | Cianna Medical, Inc. | 2010-07-12 | 54 | 0 |
| K081677 | SAVI APPLICATOR KIT | Cianna Medical, Inc. | 2008-07-22 | 35 | 0 |
| K080565 | MODIFICATION TO: SAVI APPLICATOR KIT | Cianna Medical, Inc. | 2008-04-04 | 35 | 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