Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Soniquence, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
413 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026-01-27 | 29 | 0 |
| K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022-09-02 | 413 | 0 |
| K220071 | Soniquence Reusable Neutral Plate | Soniquence, LLC | 2022-02-03 | 24 | 0 |
| K211946 | Soniquence Reusable Bipolar Cable | Soniquence, LLC | 2021-07-16 | 23 | 0 |
| K190336 | Soniquence Bipolar Electrodes | Soniquence, LLC | 2019-06-20 | 126 | 0 |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019-05-22 | 147 | 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