Cardio Flow Inc.,: FDA clearances and approvals
Cardio Flow Inc., has 5 FDA 510(k) clearances (first 2022, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 99 days. Since 2017 its median was 99 days, against 114 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 99 |
| 2023 | 1 | 120 |
| 2024 | 2 | 76 |
| 2025 | 1 | 46 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cardio Flow Inc.,'s cleared 510(k)s took a median 99 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 4 | 4 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Cardio Flow Inc., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | MCW | 2025-04-25 | 46 |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy System | MCW | 2024-11-05 | 41 |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | MCW | 2024-02-15 | 111 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | MCW | 2023-09-27 | 120 |
| K213834 | Cardio Flow Peripheral Guide Wire | DQX | 2022-03-18 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Cardio Flow 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.
Device clinical trials
Cardio Flow Inc., is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03635190: Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (Completed, started 2018-12-17)
- NCT03365154: Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) (Completed, started 2018-01-25)
Frequently asked questions
How many FDA 510(k) clearances does Cardio Flow Inc., have?
Cardio Flow Inc., has 5 FDA 510(k) clearances (first 2022, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Cardio Flow Inc.,'s 510(k)s?
The median time from FDA receipt to decision across Cardio Flow Inc.,'s cleared 510(k)s is 99 days. Since 2017: 99 days, versus 114 days for all cleared 510(k)s in the same product codes.
What devices does Cardio Flow Inc., make?
Its most frequent FDA product codes are MCW (Catheter, Peripheral, Atherectomy, 4); DQX (Wire, Guide, Catheter, 1).
Has Cardio Flow Inc., had device recalls?
openFDA lists no recalls under a recalling firm name matching Cardio Flow Inc.,. Related entities may recall under other names.
Next steps
- See all 5 Cardio Flow Inc., clearances with predicates and recalls
- Run predicate analysis for product code MCW, Cardio Flow 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.