Recor Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Recor Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYI | Ablation Catheter, Renal Denervation | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220023 | PMA | Paradise® Ultrasound Renal Denervation System | 2023-11-07 |
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2026-01-29.
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 Recor Medical, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:
- NCT07231757: The RADIANCE CED Study (Recruiting, started 2025-11-21)
- NCT06297291: Global Paradise System US Post Approval Study (Recruiting, started 2024-06-28)
- NCT05017935: RADIANCE Continued Access Protocol (Active not recruiting, started 2022-05-04)
- NCT05027685: The "Global Paradise System" Registry (Recruiting, started 2022-01-13)
- NCT03614260: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension (Active not recruiting, started 2018-12-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Recor Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Recor Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Recor Medical, Inc.?
The most frequent FDA product codes under this applicant name are QYI (Ablation Catheter, Renal Denervation, 1).
Next steps
- See all 0 Recor Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QYI, Recor 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.