S4 Medical Corp.: FDA clearances and approvals
S4 Medical Corp. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 31 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 31 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, S4 Medical Corp.'s cleared 510(k)s took a median 31 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 31 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QXU | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation | 2 | 1 |
Review panels
- Cardiovascular (2)
Most recent S4 Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243233 | esolution® Esophageal Retractor | QXU | 2024-11-09 | 31 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230006 | De Novo | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation | 2023-09-06 |
Recalls
openFDA lists no recalls under a recalling firm named S4 Medical Corp..
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.
Device clinical trials
S4 Medical Corp. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04659213: Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY (Completed, started 2021-09-01)
Frequently asked questions
How many FDA 510(k) clearances does S4 Medical Corp. have?
S4 Medical Corp. has 1 FDA 510(k) clearance (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear S4 Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across S4 Medical Corp.'s cleared 510(k)s is 31 days.
What devices does S4 Medical Corp. make?
Its most frequent FDA product codes are QXU (Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation, 2).
Has S4 Medical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching S4 Medical Corp. Related entities may recall under other names.
Next steps
- See all 1 S4 Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code QXU, S4 Medical Corp.'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.