510(k) · Cleared
ClearedVIVA combo RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starmed Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 8, 2017 as substantially equivalent to K042216 (Valleylab, 2004) after a 90-day review. Its family tree reaches back 5 generations to 1987. 7 later devices descend from it.
- Decided
- Mar 8, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870028 (1987). 16 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 4 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 3 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 2 generations backK021329 Rita SystemRita Medical Systems · 2002
- 1 generation backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- This deviceK163450 VIVA combo RF SystemStarmed Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK183538 VIVA combo RF SystemStarmed Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK234140 VIVA combo RF System (VIVA combo RF System)Starmed Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK172012 star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK252833 VIVA combo RF SystemStarmed Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183538VIVA combo RF SystemStarmed Co., Ltd. · 2019 · cites it directly2descendants
- K240932HybridTherm SystemErbe Elektromedizin GmbH · 2024 · cites it directly1descendant
- K234140VIVA combo RF System (VIVA combo RF System)Starmed Co., Ltd. · 2024 · 2 generations on1descendant
- K172012star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd. · 2018 · cites it directly1descendant
- K252833VIVA combo RF SystemStarmed Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −4 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −3 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −2 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −1 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| 0 (this device) | K163450 | VIVA combo RF System | Starmed Co., Ltd. | 2017 | — |
| +1 | K183538 | VIVA combo RF System | Starmed Co., Ltd. | 2019 | — |
| +1 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +2 | K234140 | VIVA combo RF System (VIVA combo RF System) | Starmed Co., Ltd. | 2024 | — |
| +1 | K172012 | star RF Electrode, VIVA RF Electrode | Starmed Co., Ltd. | 2018 | — |
| +3 | K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K042216 | Cool-Tip RF Ablation SystemSummary page 5…on of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate Device 510(k) Number: K042216 Applicant: Valleylab Regulation Name: Electrosurgical cutting and coagulation device and accessories … | 2004 |
What descends from it? (7)
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 30 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K183538 (Starmed Co., Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K042216.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163450: VIVA combo RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163450
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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