Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Flow Inc., — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
120 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250723 | FreedomFlow™ Orbital Circumferential Atherectomy System (H60 | Cardio Flow Inc., | 2025-04-25 | 46 | 0 |
| K242947 | FreedomFlow™ Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2024-11-05 | 41 | 0 |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H600 | Cardio Flow Inc., | 2024-02-15 | 111 | 0 |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., | 2023-09-27 | 120 | 0 |
| K213834 | Cardio Flow Peripheral Guide Wire | Cardio Flow Inc., | 2022-03-18 | 99 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda