Cardiosense, Inc.: FDA clearances and approvals
Cardiosense, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 246 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 246 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cardiosense, Inc.'s cleared 510(k)s took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXR | Ballistocardiograph | 1 | 1 |
| SIF | Software Device System For Estimation Of Cardiac Pressures | 1 | 0 |
Review panels
- Cardiovascular (2)
Most recent Cardiosense, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243566 | CardioTag | DXR | 2025-07-22 | 246 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250057 | De Novo | Software Device System For Estimation Of Cardiac Pressures | 2026-05-22 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiosense, 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.
Frequently asked questions
How many FDA 510(k) clearances does Cardiosense, Inc. have?
Cardiosense, Inc. has 1 FDA 510(k) clearance (first 2025, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Cardiosense, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cardiosense, Inc.'s cleared 510(k)s is 246 days.
What devices does Cardiosense, Inc. make?
Its most frequent FDA product codes are DXR (Ballistocardiograph, 1); SIF (Software Device System For Estimation Of Cardiac Pressures, 1).
Has Cardiosense, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardiosense, Inc. Related entities may recall under other names.
Next steps
- See all 1 Cardiosense, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXR, Cardiosense, 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.