510(k) · Cleared
Recalled · Class II · 2013Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 15, 2012 as substantially equivalent to K101139 (Medtronic, Inc., 2010) and 2 other predicates after a 365-day review. Its family tree reaches back 4 generations to 1995. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 15, 2012
- Review
- 365 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951245 (1995). 9 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 3 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 2 generations backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- 1 generation backK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
- This deviceK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK150786 Rezum SystemNxthera, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK180237 Rezum SystemNxthera, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc. · 2015 · cites it directly8descendants
- K150786Rezum SystemNxthera, Inc. · 2015 · cites it directly7descendants
- K160417Rezum SystemNxthera, Inc. · 2016 · 2 generations on5descendants
- K180237Rezum SystemNxthera, Inc. · 2018 · 3 generations on4descendants
- K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −3 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −2 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| −1 | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | 1 |
| 0 (this device) | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | Medtronic, Inc. | 2012 | — |
| +1 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… | Urologix, Inc. | 2015 | — |
| +1 | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| +2 | K160417 | Rezum System | Nxthera, Inc. | 2016 | 1 |
| +3 | K180237 | Rezum System | Nxthera, Inc. | 2018 | — |
| +4 | K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K101139 | Prostiva RF Therapy Model 8929 Hand PieceSummary page 1…nit and accessories Regulatory Classification: Class 11 Product Code: KNS and GEl Name of Predicate Device: Prostiva RE Therapy Model 8929 Hand Piece (K101 139) TUNA Therapy Model 8930 RE Generator (K052413) TUNA Therapy Model 8934 Retur… | 2010 |
| * | K052413 | Tuna System, Models 8909, 8929, 8930, 8934Summary page 1…KNS and GEl Name of Predicate Device: Prostiva RE Therapy Model 8929 Hand Piece (K101 139) TUNA Therapy Model 8930 RE Generator (K052413) TUNA Therapy Model 8934 Return Electrode (K052413) TUNA Therapy Model 6 101… | 2005 |
| * | K002583 | Tuna (Trans Urethra Needle) Office SystemSummary page 1…930 RE Generator (K052413) TUNA Therapy Model 8934 Return Electrode (K052413) TUNA Therapy Model 6 101 Tubing System (K0025 83) TUNA Therapy Model 8099 Telescope (K002583) Device Description Prostiva RF Therapy is a minimally inva… | 2001 |
What descends from it? (9)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class II | Z-0182-2014 | Process change control | A Hand Piece high deployment force exceeded the maximum specification. |
| Feb 27, 2013 | Class II | Z-1031-2013 | Nonconforming Material/Component | Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K142248 (Urologix, Inc., 2015) has gone furthest, with 8 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. 2012, 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 Prostiva, REF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113380: Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113380
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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