510(k) · Cleared
ClearedRezum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nxthera, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 27, 2015 as substantially equivalent to K113380 (Medtronic, Inc., 2012) and 1 other predicate after a 155-day review. Its family tree reaches back 6 generations to 1995. 7 later devices descend from it.
- Decided
- Aug 27, 2015
- Review
- 155 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K951245 (1995). 11 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 5 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 4 generations backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- 3 generations backK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
- 2 generations backK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
- 1 generation backK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- This deviceK150786 Rezum SystemNxthera, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK160417 Rezum SystemNxthera, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 4 of its ownK180237 Rezum SystemNxthera, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
- Descendant · 4 generations on · 2 of its ownK191505 Rezum SystemNxthera (A Boston Scientific Company) · 2019
- Descendant · 5 generations on · 1 of its ownK250584 Rezum SystemBoston Scientific Corporation · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160417Rezum SystemNxthera, Inc. · 2016 · cites it directly5descendants
- K180237Rezum SystemNxthera, Inc. · 2018 · 2 generations on4descendants
- K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019 · 3 generations on3descendants
- K191505Rezum SystemNxthera (A Boston Scientific Company) · 2019 · 4 generations on2descendants
- K250584Rezum SystemBoston Scientific Corporation · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −5 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −4 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| −3 | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | 1 |
| −2 | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator | Medtronic, Inc. | 2012 | 2 |
| −1 | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF… | Urologix, Inc. | 2015 | — |
| 0 (this device) | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| +1 | K160417 | Rezum System | Nxthera, Inc. | 2016 | 1 |
| +2 | K180237 | Rezum System | Nxthera, Inc. | 2018 | — |
| +3 | K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019 | — |
| +4 | K191505 | Rezum System | Nxthera (A Boston Scientific Company) | 2019 | — |
| +5 | K250584 | Rezum System | Boston Scientific Corporation | 2025 | — |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K113380 | Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorSummary page 4…btain marketing clearance for a new device – the Rezūm System. 1.5 PREDICATE DEVICE The Rezūm System is substantially equivalent to the Medtronic Prostiva devices (K113380 and K142248). 1.6 DEVICE DESCRIPTION The reusable Rezūm Generator is provided with the following reusable components: x… | 2012 |
| * | K142248 | Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy…Summary page 4…ing clearance for a new device – the Rezūm System. 1.5 PREDICATE DEVICE The Rezūm System is substantially equivalent to the Medtronic Prostiva devices (K113380 and K142248). 1.6 DEVICE DESCRIPTION The reusable Rezūm Generator is provided with the following reusable components: x Generator… | 2015 |
What descends from it? (7)
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)
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 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K160417 (Nxthera, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K113380.
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. 2015, 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 Reziim System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men > 50 years of age with a prostate volume > 30cm® and < 80cm®.
The Reziim 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/K150786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150786: 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/K150786
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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