Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Soliton, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
213 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212502 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-11-05 | 88 | 0 |
| K210964 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-04-27 | 27 | 0 |
| K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2021-01-29 | 213 | 0 |
| K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2020-03-10 | 29 | 0 |
| K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | 2019-05-24 | 81 | 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