Saranas, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Saranas, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 114 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Saranas, Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QFJ | Intravascular Bleed Monitor | 2 | 1 |
Review panels
- Cardiovascular (2)
Most recent Saranas, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230273 | Saranas Early Bird Bleed Monitoring System | QFJ | 2023-05-25 | 114 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180021 | De Novo | Intravascular Bleed Monitor | 2019-03-01 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-08-10.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Saranas, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05077657: Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System (Completed, started 2021-11-29)
- NCT03621202: Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events (Completed, started 2018-08-13)
Frequently asked questions
How many FDA 510(k) clearances are listed under Saranas, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Saranas, Inc.” (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Saranas, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Saranas, Inc. is 114 days.
Which FDA product codes appear under Saranas, Inc.?
The most frequent FDA product codes under this applicant name are QFJ (Intravascular Bleed Monitor, 2).
Next steps
- See all 1 Saranas, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QFJ, Saranas, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.