510(k) · Cleared
ClearedProstiva RF Therapy Model 8929 Hand Piece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 21, 2010 after a 29-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK101139 Prostiva RF Therapy Model 8929 Hand PieceMedtronic, Inc. · 2010
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K101139 | Prostiva RF Therapy Model 8929 Hand Piece | Medtronic, Inc. | 2010 | — |
| +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 | — |
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? (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 |
|---|---|---|---|
| * | — | Prostiva RF Therapy Model 8929 Hand Piece Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113380 (Medtronic, Inc., 2012) has gone furthest, with 9 descendants of its own.
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. 2010, 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 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 cm'.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101139: Prostiva RF Therapy Model 8929 Hand Piece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101139
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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