Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venclose, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter | Venclose, Inc. | 2025-08-19 | 25 | 0 |
| K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | 2025-02-04 | 25 | 1 |
| K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Mave | Venclose, Inc. | 2021-08-03 | 53 | 1 |
| K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Cath | Venclose, Inc. | 2016-09-09 | 175 | 2 |
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