510(k) · Cleared
Recalled · 2008Tuna System, Models 8909, 8929, 8930, 8934
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Nov 17, 2005 as substantially equivalent to K014224 (Vidamed, Inc., 2002) and 3 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Nov 17, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K951245 (1995). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 2 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 1 generation backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- This deviceK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005
- Descendant · cites it directly · 9 of its ownK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK150786 Rezum SystemNxthera, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 4 of its ownK180237 Rezum SystemNxthera, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · cites it directly9descendants
- K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Urologix, Inc. · 2015 · 2 generations on8descendants
- K150786Rezum SystemNxthera, Inc. · 2015 · 2 generations on7descendants
- K160417Rezum SystemNxthera, Inc. · 2016 · 3 generations on5descendants
- K180237Rezum SystemNxthera, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −2 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −1 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| 0 (this device) | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | — |
| +1 | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | Medtronic, Inc. | 2012 | 2 |
| +2 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… | Urologix, Inc. | 2015 | — |
| +2 | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| +3 | K160417 | Rezum System | Nxthera, Inc. | 2016 | 1 |
| +4 | K180237 | Rezum System | Nxthera, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K014224 | Precision Plus Tuna Office SystemSummary page 1…accessories. 876.4300 Endoscopic electrosurgical unit and accessories Name of Predicate Device Precision Plus TUNA Office System (K014224) TUNA Office System (Precision) (K002583) Model 7600 RF Generator… | 2002 |
| * | K002583 | Tuna (Trans Urethra Needle) Office SystemSummary page 1…urgical unit and accessories Name of Predicate Device Precision Plus TUNA Office System (K014224) TUNA Office System (Precision) (K002583) Model 7600 RF Generator (965061) TUNA 3 (K960918) Device Descri… | 2001 |
| * | K965061 | Vidamed Modedl 7600 RF GeneratorSummary page 2…14224) Generator Medtronic Model 7800 RF Generator (K002583) Medtronic Model 7600 RF Generator (K965061) TUNA Therapy Model 8929 Hand Piece Medtronic Model TUNA 3 Cartridge (K960918) M… | 1997 |
| * | K960918 | Vidamed Tuna (Transurethral Needle Ablation) SystemSummary page 1…TUNA Office System (Precision) (K002583) Model 7600 RF Generator (965061) TUNA 3 (K960918) Device Description This premarket notification is being submitted for additional components of the Medtronic TUNA System to cre… | 1996 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | 2012 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2008 | Not classified | Z-1060-2009 | Device Design | Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K113380 (Medtronic, Inc., 2012) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K014224.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The TUNA System is indicated for use in 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 cc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052413: Tuna System, Models 8909, 8929, 8930, 8934.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052413
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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