CSA Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “CSA Medical, Inc.” (first 2007, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 61 days. Since 2017 the median was 89 days, against 88 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2012 | 1 | 119 |
| 2013 | 0 | — |
| 2014 | 1 | 239 |
| 2015 | 3 | 27 |
| 2016 | 2 | 39 |
| 2017 | 4 | 70 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 220 |
| 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 CSA Medical, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 14 | 14 |
Review panels
Most recent CSA Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201183 | Vortex Radial Spray Catheter | GEH | 2020-12-07 | 220 |
| K171626 | truFreeze System | GEH | 2017-08-30 | 89 |
| K172041 | truFreeze System | GEH | 2017-07-27 | 21 |
| K171522 | truFreeze Rapid AV Spray Kit | GEH | 2017-07-14 | 50 |
| K163244 | truFreeze System | GEH | 2017-05-24 | 187 |
| K162695 | truFreeze System | GEH | 2016-10-25 | 28 |
| K161557 | truFreeze System | GEH | 2016-07-26 | 50 |
| K152668 | truFreeze System | GEH | 2015-10-14 | 27 |
| K150920 | truFreeze System | GEH | 2015-06-17 | 72 |
| K143625 | truFreeze System | GEH | 2015-01-15 | 24 |
4 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-03-25.
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 CSA Medical, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03893370: RejuvenAir® System Trial for COPD With Chronic Bronchitis (Active not recruiting, started 2020-07-09)
- NCT02483637: Safety and Feasibility Study of Rejuvenair™ for Treating Chronic Bronchitis Patients (Completed, started 2016-02)
- NCT02483052: RejuvenAir Lobectomy for Safety and Histology (Completed, started 2015-08)
- NCT02106143: RejuvenAir™ System Lobectomy Safety and Histology Study (Completed, started 2014-09)
- NCT00754468: Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus. (Completed, started 2009-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under CSA Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “CSA Medical, Inc.” (first 2007, latest 2020), 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 CSA Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CSA Medical, Inc. is 61 days. Since 2017: 89 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CSA Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 14).
Next steps
- See all 14 CSA Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, CSA 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.