510(k) Report

FDA applicant

Soniquence, LLC

Baldwin, NY6 decisions2019–20260 recalls

FDA records 6 decisions for Soniquence, LLC (Baldwin, NY) from 2019 to 2026: 6 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 78 days from receipt to decision, against 148 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Soniquence, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2019: 22021: 12022: 22026 (partial year): 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Soniquence, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 78 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 148 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 20194cite it
  • K190336Soniquence Bipolar ElectrodesSoniquence, LLC · 20192cite it
  • K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 20221cites it

What has FDA decided for it lately?

  • K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026
  • K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022
  • K220071Soniquence Reusable Neutral PlateSoniquence, LLC · 2022
  • K211946Soniquence Reusable Bipolar CableSoniquence, LLC · 2021
  • K190336Soniquence Bipolar ElectrodesSoniquence, LLC · 2019
  • K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019

All 6 as Soniquence, LLC →