510(k) Report

510(k) · Cleared

Cleared

Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope

K142248510(k) TraditionalCleared Feb 20, 2015190-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Urologix, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 20, 2015 as substantially equivalent to K113380 (Medtronic, Inc., 2012) after a 190-day review. Its family tree reaches back 5 generations to 1995. 8 later devices descend from it.

Decided
Feb 20, 2015
Review
190 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K951245 (1995). 10 ancestors in all. 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2001: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant cleared2025: 2 descendants cleared2018: 1 descendant cleared2019: 2 descendants cleared2026: 1 descendant clearedK951245 · Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory · Vidamed, Inc. · 1995×2: 2 generations cleared close together, K960918 (1996), K965061 (1997) K052413 · Tuna System, Models 8909, 8929, 8930, 8934 · Medtronic Vascular · 2005 · recalledK113380 · Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator · Medtronic, Inc. · 2012 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K113380 · Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator · Medtronic, Inc. · 2012 · recalledK052413 · Tuna System, Models 8909, 8929, 8930, 8934 · Medtronic Vascular · 2005 · recalledK965061 · Vidamed Modedl 7600 RF Generator · Vidamed, Inc. · 1997K960918 · Vidamed Tuna (Transurethral Needle Ablation) System · Vidamed, Inc. · 1996K951245 · Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory · Vidamed, Inc. · 1995−50+5
  1. Root · 5 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
  2. 4 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
  3. 3 generations backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
  4. 2 generations backK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
  5. 1 generation backK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
  6. This deviceK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
  7. Descendant · cites it directly · 7 of its ownK150786 Rezum SystemNxthera, Inc. · 2015
  8. Descendant · 2 generations on · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
  9. Descendant · 3 generations on · 4 of its ownK180237 Rezum SystemNxthera, Inc. · 2018
  10. Descendant · 4 generations on · 3 of its ownK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
  11. Descendant · 5 generations on · 2 of its ownK191505 Rezum SystemNxthera (A Boston Scientific Company) · 2019

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12018: 12019: 22025: 22026: 1
2015high 2 (2019) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • 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
  • K191505Rezum SystemNxthera (A Boston Scientific Company) · 2019 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K951245Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical…Vidamed, Inc.1995—
−4K960918Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc.1996—
−3K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc.1997—
−2K052413Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular20051
−1K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc.20122
0 (this device)K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF…Urologix, Inc.2015—
+1K150786Rezum SystemNxthera, Inc.2015—
+2K160417Rezum SystemNxthera, Inc.20161
+3K180237Rezum SystemNxthera, Inc.2018—
+4K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company)2019—
+5K191505Rezum SystemNxthera (A Boston Scientific Company)2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
200110
200210
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201810
201920
202520
202610
FIG. 1 — Lineage of K142248, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K113380Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator
Summary page 4
…ethral needle ablation Product Code GEI, KNS Classification Class II Panel Gastroenterology/Urology Predicate Device Prostiva RF Therapy System (K113380) Name Device Prostiva RF Therapy is a minimally invasive treatment for Description patients with lower urinary…
Medtronic, Inc.20122

Also cleared against K113380: 1 other device →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150786Rezum SystemNxthera, Inc.20157

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 20 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K150786 (Nxthera, Inc., 2015) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K113380.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Prostiva RF 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 cm3.

Indications for use as stated in the FDA summary.

Also cleared against K113380

1 other device cites the same predicate.

  • K150786Rezum SystemNxthera, Inc. · 2015

More from Urologix, Inc.

28 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K142248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142248: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142248

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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