510(k) · Cleared
ClearedSoniquence Reusable 3 Button Fingerswitch Wand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soniquence, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 2, 2022 as substantially equivalent to K183611 (Soniquence, LLC, 2019) after a 413-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Sep 2, 2022
- Review
- 413 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933157 (1994). 33 ancestors in all, the oldest K780977 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 6 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 5 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 4 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 3 generations backK142410 Elliquence ElectrodesElliquence, LLC · 2015
- 2 generations backK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
- 1 generation backK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019
- This deviceK212222 Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022
- Descendant · cites it directly · 0 of its ownK254220 Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −6 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −5 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −4 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −3 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
| −2 | K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016 | — |
| −1 | K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019 | — |
| 0 (this device) | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022 | — |
| +1 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183611 | Soniquence RF Generator and Soniquence ElectrodesSummary page 5…oniquence.com Page 1 of 2 K212222 Predicate Devices (807.92(a)(3)) • Soniquence Disposable 3 Button Fingerswitch Handpiece (K183611) Device Description (807.92(a)(4)) The subject device Soniquence Reusable 3 Button Fingerswitch Wand is an accessory to the Son… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254220 | Reusable 3 Button Fingerswitch Wand | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K254220 (Soniquence, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K183611.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212222: Soniquence Reusable 3 Button Fingerswitch Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026