510(k) · Cleared
ClearedViveve 2.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viveve, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 2, 2022 as substantially equivalent to K212678 (Viveve Medical, Inc., 2021) after a 57-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Feb 2, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 31 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK190422 Viveve System 2.0Viveve Medical · 2019
- 2 generations backK193611 Viveve 2.0 SystemViveve Medical, Inc. · 2020
- 1 generation backK212678 Viveve System, Viveve 2.0 SystemViveve Medical, Inc. · 2021
- This deviceK213814 Viveve 2.0 SystemViveve, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK082962 Tivamed Cooled RF System, Model 78001Tivamed, Inc. · 2008
- 5 generations backK162547 Viveve SystemViveve, Inc. · 2016
- 4 generations backK180584 Viveve RF System, SecureViveve, Inc. · 2018
- 3 generations backK190422 Viveve System 2.0Viveve Medical · 2019
- 2 generations backK193611 Viveve 2.0 SystemViveve Medical, Inc. · 2020
- 1 generation backK212678 Viveve System, Viveve 2.0 SystemViveve Medical, Inc. · 2021
- This deviceK213814 Viveve 2.0 SystemViveve, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K082962 | Tivamed Cooled RF System, Model 78001 | Tivamed, Inc. | 2008 | — |
| −5 | K162547 | Viveve System | Viveve, Inc. | 2016 | — |
| −4 | K180584 | Viveve RF System, Secure | Viveve, Inc. | 2018 | — |
| −3 | K190422 | Viveve System 2.0 | Viveve Medical | 2019 | — |
| −2 | K193611 | Viveve 2.0 System | Viveve Medical, Inc. | 2020 | — |
| −1 | K212678 | Viveve System, Viveve 2.0 System | Viveve Medical, Inc. | 2021 | — |
| 0 (this device) | K213814 | Viveve 2.0 System | Viveve, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K212678 | Viveve System, Viveve 2.0 SystemSummary page 4…CFR 878.4400) Device Panel: General Surgery/Restorative Device Device Classification: Class II 1.4 PREDICATE DEVICE Viveve® 2.0 System (K212678) 1.5 DEVICE DESCRIPTION The Viveve 2.0 System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume o… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 31 ancestors have a recall of any class.
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 Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213814 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213814: Viveve 2.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213814
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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