Soniquence, LLC: FDA clearances and approvals
Soniquence, LLC has 6 FDA 510(k) clearances (first 2019, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 78 days. Since 2017 its median was 78 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 136 |
| 2020 | 0 | — |
| 2021 | 1 | 23 |
| 2022 | 2 | 218 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, Soniquence, LLC's cleared 510(k)s took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
Review panels
Most recent Soniquence, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254220 | Reusable 3 Button Fingerswitch Wand | GEI | 2026-01-27 | 29 |
| K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | GEI | 2022-09-02 | 413 |
| K220071 | Soniquence Reusable Neutral Plate | GEI | 2022-02-03 | 24 |
| K211946 | Soniquence Reusable Bipolar Cable | GEI | 2021-07-16 | 23 |
| K190336 | Soniquence Bipolar Electrodes | GEI | 2019-06-20 | 126 |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | GEI | 2019-05-22 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Soniquence, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Soniquence, LLC have?
Soniquence, LLC has 6 FDA 510(k) clearances (first 2019, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Soniquence, LLC's 510(k)s?
The median time from FDA receipt to decision across Soniquence, LLC's cleared 510(k)s is 78 days. Since 2017: 78 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Soniquence, LLC make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6).
Has Soniquence, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Soniquence, LLC. Related entities may recall under other names.
Next steps
- See all 6 Soniquence, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Soniquence, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.