510(k) · Cleared
Recalled · Class II · 2017Rezum 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 Mar 17, 2016 as substantially equivalent to K150786 (Nxthera, Inc., 2015) after a 30-day review. Its family tree reaches back 7 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K951245 (1995). 12 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 6 generations backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- 5 generations backK965061 Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
- 4 generations backK052413 Tuna System, Models 8909, 8929, 8930, 8934Medtronic Vascular · 2005 · Recalled
- 3 generations backK113380 Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF GeneratorMedtronic, Inc. · 2012 · Recalled
- 2 generations backK142248 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece…Urologix, Inc. · 2015
- 1 generation backK150786 Rezum SystemNxthera, Inc. · 2015
- This deviceK160417 Rezum SystemNxthera, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK180237 Rezum SystemNxthera, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK190093 Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019
- Descendant · 3 generations on · 2 of its ownK191505 Rezum SystemNxthera (A Boston Scientific Company) · 2019
- Descendant · 4 generations on · 1 of its ownK250584 Rezum SystemBoston Scientific Corporation · 2025
- Descendant · 5 generations on · 0 of its ownK262460 Rezum SystemBoston Scientific · 2026
Most influential descendants
Showing 5 of 5 · See all- K180237Rezum SystemNxthera, Inc. · 2018 · cites it directly4descendants
- K190093Rezum Delivery Device, Rezum GeneratorNxthera (A Boston Scientific Company) · 2019 · 2 generations on3descendants
- K191505Rezum SystemNxthera (A Boston Scientific Company) · 2019 · 3 generations on2descendants
- K250584Rezum SystemBoston Scientific Corporation · 2025 · 4 generations on1descendant
- K262460Rezum SystemBoston Scientific · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −6 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| −5 | K965061 | Vidamed Modedl 7600 RF Generator | Vidamed, Inc. | 1997 | — |
| −4 | K052413 | Tuna System, Models 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005 | 1 |
| −3 | 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 | — |
| −1 | K150786 | Rezum System | Nxthera, Inc. | 2015 | — |
| 0 (this device) | K160417 | Rezum System | Nxthera, Inc. | 2016 | — |
| +1 | K180237 | Rezum System | Nxthera, Inc. | 2018 | — |
| +2 | K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019 | — |
| +3 | K191505 | Rezum System | Nxthera (A Boston Scientific Company) | 2019 | — |
| +4 | K250584 | Rezum System | Boston Scientific Corporation | 2025 | — |
| +5 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K150786 | Rezum SystemSummary page 4…Product Code KNS 8.2 PREDICATE DEVICE The modified device is substantially equivalent to the NxThera Rezūm System (K150786). PAGE 8-1… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180237 | Rezum System | 2018 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2017 | Class II | Z-0262-2018 | Nonconforming Material/Component | Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K180237 (Nxthera, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K150786.
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. 2016, 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 BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160417: Rezum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160417
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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