510(k) · Cleared
ClearedHybridTherm System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe Elektromedizin GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 5, 2024 as substantially equivalent to K181249 (Starmed Co., Ltd., 2018) and 4 other predicates after a 122-day review. Its family tree reaches back 6 generations to 1987. 1 of the 37 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 5, 2024
- Review
- 122 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K870028 (1987). 35 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 3 generations backK021329 Rita SystemRita Medical Systems · 2002
- 2 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 1 generation backK163450 VIVA combo RF SystemStarmed Co., Ltd. · 2017
- This deviceK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · cites it directly · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
Class I recalls in this family
- K190651 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal…direct predicate · 2020
Most influential descendants
Showing 1 of 1 · See all- K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −5 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −4 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −3 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −2 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −1 | K163450 | VIVA combo RF System | Starmed Co., Ltd. | 2017 | — |
| 0 (this device) | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +1 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K181249 | EUSRA RF ElectrodeSummary page 5…GEI & JOS GEH Legally Marketed Predicate Devices Primary EUSRA RF Electrode - K181249 Additional predicate devices VIVA combo RF System… | 2018 |
| * | K163450 | VIVA combo RF SystemSummary page 5…EUSRA RF Electrode - K181249 Additional predicate devices VIVA combo RF System - K163450 Erbe ESU Model VIO 3 - K190823 Single Use Electrosu… | 2017 |
| * | K190823 | Erbe ESU Model VIO 3 with AccessoriesSummary page 5…Additional predicate devices VIVA combo RF System - K163450 Erbe ESU Model VIO 3 - K190823 Single Use Electrosurgical pencil - K192542 ERBECRY… | 2019 |
| * | K192542 | Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch…Summary page 5…ombo RF System - K163450 Erbe ESU Model VIO 3 - K190823 Single Use Electrosurgical pencil - K192542 ERBECRYO 2 - K190651 Erbe Elektromedizin GmbH K240932… | 2020 |
| * | K190651 | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO…Summary page 5…Erbe ESU Model VIO 3 - K190823 Single Use Electrosurgical pencil - K192542 ERBECRYO 2 - K190651 Erbe Elektromedizin GmbH K240932 Page 2 of 11 Traditional 51… | 2020 |
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 |
|---|---|---|---|
| K251108 | Erbe ESU Model VIO® 3n with Accessories | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch…Erbe Elektromedizin GmbH · 2020 · Direct predicate · ◆ in the 2020 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- 6 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251108 (Erbe Elektromedizin GmbH, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.
The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion, devitalization (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.
The HybridTherm probes are intended for ablation and coagulation of soft tissue.
The following probes can also be used for cutting tissue:
HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240932 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240932: HybridTherm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240932
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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