510(k) · Cleared
ClearedRezum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Sep 3, 2026 as substantially equivalent to K250584 (Boston Scientific Corporation, 2025) after a 48-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Sep 3, 2026
- Review
- 48 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K951245 (1995). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 8 generations between
- 3 generations backK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
- 2 generations backK191505 Rezum SystemNxthera (A Boston Scientific Company) · 2019
- 1 generation backK250584 Rezum SystemBoston Scientific Corporation · 2025
- This deviceK262460 Rezum SystemBoston Scientific · 2026
Show all 12 generations
- Root · 12 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 11 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 10 generations backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- 9 generations backK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
- 8 generations backK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
- 7 generations backK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- 6 generations backK150786 Rezum SystemNxthera, Inc. · 2015
- 5 generations backK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
- 4 generations backK180237 Rezum SystemNxthera, Inc. · 2018
- 3 generations backK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
- 2 generations backK191505 Rezum SystemNxthera (A Boston Scientific Company) · 2019
- 1 generation backK250584 Rezum SystemBoston Scientific Corporation · 2025
- This deviceK262460 Rezum SystemBoston Scientific · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −11 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −10 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| −9 | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | 1 |
| −8 | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | Medtronic, Inc. | 2012 | 2 |
| −7 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… | Urologix, Inc. | 2015 | — |
| −6 | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| −5 | K160417 | Rezum System | Nxthera, Inc. | 2016 | 1 |
| −4 | K180237 | Rezum System | Nxthera, Inc. | 2018 | — |
| −3 | K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019 | — |
| −2 | K191505 | Rezum System | Nxthera (A Boston Scientific Company) | 2019 | — |
| −1 | K250584 | Rezum System | Boston Scientific Corporation | 2025 | — |
| 0 (this device) | K262460 | Rezum System | Boston Scientific | 2026 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K250584 | Rezum SystemSummary page 5…cation Class II Product Code KNS 510(k) Submitter/Holder Boston Scientific Corporation 510(k) #/Clearance Date K250584/Cleared June 11, 2025 Page 1 of 3 =… | 2025 |
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 31 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 17 ancestors have a recall of any class.
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. 2026, this device’s year, is highlighted.
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 Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm3 ≤ 150 cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262460: Rezum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262460
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026