Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Volta Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
149 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251518 | Volta AF-Xplorer II | Volta Medical | 2025-09-12 | 119 | 0 |
| K243812 | Volta AF-Xplorer | Volta Medical | 2025-05-09 | 149 | 0 |
| K232616 | Volta AF-Xplorer | Volta Medical | 2023-09-27 | 30 | 0 |
| K223516 | VX1+ | Volta Medical | 2023-01-21 | 60 | 0 |
| K201298 | VX1 | Volta Medical | 2020-09-16 | 124 | 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