Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viasonix , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
237 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix , Ltd. | 2024-12-18 | 105 | 0 |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot | Viasonix , Ltd. | 2021-01-25 | 129 | 0 |
| K192607 | LiteWalk | Viasonix , Ltd. | 2019-12-19 | 90 | 0 |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix , Ltd. | 2019-05-16 | 29 | 0 |
| K170859 | Dolphin/IQ and Dolphin/4D | Viasonix , Ltd. | 2017-11-14 | 237 | 0 |
| K111416 | FALCON | Viasonix , Ltd. | 2011-07-15 | 56 | 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