Cianna Medical, Inc.: FDA clearances and approvals
Cianna Medical, Inc. has 10 FDA 510(k) clearances (first 2008, latest 2018), across 4 product codes in 2 review panels. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 222 |
| 2014 | 1 | 99 |
| 2015 | 0 | — |
| 2016 | 1 | 58 |
| 2017 | 1 | 139 |
| 2018 | 1 | 107 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cianna Medical, Inc.'s cleared 510(k)s took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 4 | 4 |
| NEU | Marker, Radiographic, Implantable | 3 | 3 |
| PDW | Internal Tissue Marker | 2 | 2 |
| PBY | Temporary Tissue Marker | 1 | 1 |
Review panels
Most recent Cianna Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | NEU | 2018-08-02 | 107 |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | NEU | 2017-10-31 | 139 |
| K161507 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | PDW | 2016-07-29 | 58 |
| K141318 | CIANNA MEDICAL SGS SYSTEM | PDW | 2014-08-27 | 99 |
| K132463 | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM | NEU | 2013-12-03 | 118 |
| K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM | PBY | 2013-02-04 | 325 |
| K103215 | CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT | JAQ | 2010-11-15 | 14 |
| K101411 | SAVI PREPARATION DEVICE | JAQ | 2010-07-12 | 54 |
| K081677 | SAVI APPLICATOR KIT | JAQ | 2008-07-22 | 35 |
| K080565 | MODIFICATION TO: SAVI APPLICATOR KIT | JAQ | 2008-04-04 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Cianna Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Cianna Medical, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Cianna Medical, Inc. have?
Cianna Medical, Inc. has 10 FDA 510(k) clearances (first 2008, latest 2018), across 4 product codes in 2 review panels.
How long does FDA take to clear Cianna Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cianna Medical, Inc.'s cleared 510(k)s is 78 days.
What devices does Cianna Medical, Inc. make?
Its most frequent FDA product codes are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 4); NEU (Marker, Radiographic, Implantable, 3); PDW (Internal Tissue Marker, 2).
Has Cianna Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cianna Medical, Inc. Related entities may recall under other names.
Next steps
- See all 10 Cianna Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Cianna Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.