Fresca Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Fresca Medical, Inc.” (first 2020, latest 2020), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 104 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 |
|---|---|---|
| 2020 | 1 | 104 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fresca Medical, Inc. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QBY | Positive Airway Pressure System | 2 | 1 |
Review panels
- Anesthesiology (2)
Most recent Fresca Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200698 | Somnera System | QBY | 2020-06-29 | 104 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170089 | De Novo | Positive Airway Pressure System | 2018-06-05 |
Recalls
openFDA lists no recalls under a recalling firm named Fresca Medical, Inc..
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 Fresca Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03999944: Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System (Completed, started 2019-10-14)
- NCT02387476: Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea (Completed, started 2014-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fresca Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Fresca Medical, Inc.” (first 2020, latest 2020), 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 Fresca Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fresca Medical, Inc. is 104 days.
Which FDA product codes appear under Fresca Medical, Inc.?
The most frequent FDA product codes under this applicant name are QBY (Positive Airway Pressure System, 2).
Next steps
- See all 1 Fresca Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QBY, Fresca Medical, 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.