De Novo · Granted
GrantedUrolift System
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
Granted on Sep 13, 2013 as a new device type through De Novo after a 190-day review. 10 later devices descend from it.
- Decided
- Sep 13, 2013
- Review
- 190 days
- Class
- Class II
- Product code
- PEW
- Recalls
- None
10 later devices descend from it, 2 citing it directly.
- This deviceDEN130023 Urolift SystemNeotract, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK133281 Neotract Urolift SystemNeotract, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK153584 NeoTract UroLift System UL500Neotract, Inc. · 2016
- Descendant · 2 generations on · 7 of its ownK162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant…Neotract, Inc. · 2016
- Descendant · 3 generations on · 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
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133281Neotract Urolift SystemNeotract, Inc. · 2013 · cites it directly9descendants
- K153584NeoTract UroLift System UL500Neotract, Inc. · 2016 · cites it directly8descendants
- K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc. · 2016 · 2 generations on7descendants
- K172359UroLift System (UL500)Neotract, Inc. · 2017 · 3 generations on6descendants
- K173087UroLift System (UL400 and UL500)Neotract, Inc. · 2017 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130023 | Urolift System | Neotract, Inc. | 2013 | — |
| +1 | K133281 | Neotract Urolift System | Neotract, Inc. | 2013 | — |
| +1 | K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016 | — |
| +2 | K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016 | — |
| +3 | K172359 | UroLift System (UL500) | Neotract, Inc. | 2017 | — |
| +2 | K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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 7.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
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?
- Of its descendants, K133281 (Neotract, Inc., 2013) has gone furthest, with 9 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. 2013, 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 | — |
https://510kreport.com/device/DEN130023 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130023: Urolift System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130023
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026