510(k) · Cleared
ClearedSoniquence RF Generator and Soniquence Electrodes
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 May 22, 2019 as substantially equivalent to K170107 (Elliquence, LLC, 2017) and 3 other predicates after a 147-day review. Its family tree reaches back 6 generations to 1994. 5 later devices descend from it.
- Decided
- May 22, 2019
- Review
- 147 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K933157 (1994). 32 ancestors in all, the oldest K780977 (1978). 5 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 5 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 4 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 3 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 2 generations backK142410 Elliquence ElectrodesElliquence, LLC · 2015
- 1 generation backK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016
- This deviceK183611 Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC · 2019
- Descendant · cites it directly · 1 of its ownK212222 Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022
- Descendant · cites it directly · 1 of its ownK202562 Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa…Ellusa, LLC · 2020
- Descendant · cites it directly · 0 of its ownK254220 Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK222425 Ellusa Reusable Neutral PlatesEllusa, LLC · 2022
- Descendant · cites it directly · 0 of its ownK220071 Soniquence Reusable Neutral PlateSoniquence, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2022 · cites it directly1descendant
- K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC · 2020 · cites it directly1descendant
- K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC · 2026 · cites it directly0descendants
- K222425Ellusa Reusable Neutral PlatesEllusa, LLC · 2022 · 2 generations on0descendants
- K220071Soniquence Reusable Neutral PlateSoniquence, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −5 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −4 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −3 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −2 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
| −1 | K160041 | Cobbra RF Tissue Dissector | Elliquence, LLC | 2016 | — |
| 0 (this device) | K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | 2019 | — |
| +1 | K212222 | Soniquence Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2022 | — |
| +1 | K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and… | Ellusa, LLC | 2020 | — |
| +1 | K254220 | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | 2026 | — |
| +2 | K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC | 2022 | — |
| +1 | K220071 | Soniquence Reusable Neutral Plate | Soniquence, LLC | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K170107 | Surgi Max UltraSummary page 5…al and Plastic Surgery Device Device Class/Product Code FDA Classification: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) x Surgi-Max® Ultra (K170107) x Bovie® IDS-310 Electrosurgical Generator (K134054) x Elliquence Electrodes (K142410) x Cobbra RF™ Tissue Dis… | 2017 |
| * | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Summary page 5…A Classification: Class II FDA Product Code: GEI Predicate Devices (807.92(a)(3)) x Surgi-Max® Ultra (K170107) x Bovie® IDS-310 Electrosurgical Generator (K134054) x Elliquence Electrodes (K142410) x Cobbra RF™ Tissue Dissector (K160041) Device Description (807.92(a)(4)) The So… | 2014 |
| * | K142410 | Elliquence ElectrodesSummary page 5…ode: GEI Predicate Devices (807.92(a)(3)) x Surgi-Max® Ultra (K170107) x Bovie® IDS-310 Electrosurgical Generator (K134054) x Elliquence Electrodes (K142410) x Cobbra RF™ Tissue Dissector (K160041) Device Description (807.92(a)(4)) The Soniquence RF Generators® are radiofrequen… | 2015 |
| * | K160041 | Cobbra RF Tissue DissectorSummary page 5…x Surgi-Max® Ultra (K170107) x Bovie® IDS-310 Electrosurgical Generator (K134054) x Elliquence Electrodes (K142410) x Cobbra RF™ Tissue Dissector (K160041) Device Description (807.92(a)(4)) The Soniquence RF Generators® are radiofrequency (RF) electrosurgical generators. It is a co… | 2016 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K212222 (Soniquence, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K170107.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 RF Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Soniquence Electrodes are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183611: Soniquence RF Generator and Soniquence Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183611
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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