510(k) · Cleared
ClearedUroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotract, Inc. · PEW Implantable Transprostatic Tissue Retractor System
Cleared on Sep 21, 2016 as substantially equivalent to K153584 (Neotract, Inc., 2016) after a 30-day review. Its family tree reaches back 3 generations to 2013. 7 later devices descend from it.
- Decided
- Sep 21, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- PEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130023 (2013). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN130023 Urolift SystemNeotract, Inc. · 2013
- 2 generations backK133281 Neotract Urolift SystemNeotract, Inc. · 2013
- 1 generation backK153584 NeoTract UroLift System UL500Neotract, Inc. · 2016
- This deviceK162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant…Neotract, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK172359 UroLift System (UL500)Neotract, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK173087 UroLift System (UL400 and UL500)Neotract, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle…Neotract, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK193269 UroLift System (UL400)Neotract, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK232558 UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172359UroLift System (UL500)Neotract, Inc. · 2017 · cites it directly6descendants
- K173087UroLift System (UL400 and UL500)Neotract, Inc. · 2017 · 2 generations on5descendants
- K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc. · 2020 · 3 generations on1descendant
- K193269UroLift System (UL400)Neotract, Inc. · 2019 · 3 generations on1descendant
- K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130023 | Urolift System | Neotract, Inc. | 2013 | — |
| −2 | K133281 | Neotract Urolift System | Neotract, Inc. | 2013 | — |
| −1 | K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016 | — |
| 0 (this device) | K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016 | — |
| +1 | K172359 | UroLift System (UL500) | Neotract, Inc. | 2017 | — |
| +2 | K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017 | 1 |
| +3 | K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2… | Neotract, Inc. | 2020 | — |
| +3 | K193269 | UroLift System (UL400) | Neotract, Inc. | 2019 | 1 |
| +4 | K232558 | UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 PEW? 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 PEW device
- #1 K232558 UroLift 2 ATC Advanced Tissue Control Systemscore 7.9 · 7 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 |
|---|---|---|---|
| * | K153584 | NeoTract UroLift System UL500Summary page 4…of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. Predicate Device UroLift System UL500, K153584, cleared to market by this Center on 15 March 2016. CONFIDENTIAL… | 2016 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172359 | UroLift System (UL500) | 2017 | 6 |
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 3 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K172359 (Neotract, Inc., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PEW devicesPEW Implantable Transprostatic Tissue Retractor System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PEW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PEW
Too few PEW 510(k)s in any year since 2007 to give a median.
Recalls per year · PEW
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEW
69in 2025
MAUDE reports naming product code PEW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 2 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 17 |
| 2019 | 2 | — | 0 | 47 |
| 2020 | 2 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 50 |
| 2022 | 0 | — | 0 | 55 |
| 2023 | 1 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 69 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
UroLift System is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
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/K162345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162345
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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