510(k) · Cleared
ClearedNeotract Urolift 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
Cleared on Dec 20, 2013 as substantially equivalent to DEN130023 (Neotract, Inc., 2013) after a 56-day review. Its family tree reaches back 1 generation to 2013. 9 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- PEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130023 (2013). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130023 Urolift SystemNeotract, Inc. · 2013
- This deviceK133281 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 · cites it directly · 5 of its ownK173087 UroLift System (UL400 and UL500)Neotract, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle…Neotract, Inc. · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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 · cites it directly5descendants
- K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130023 | Urolift System | Neotract, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017 | 1 |
| +2 | K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2… | Neotract, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 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 7.8 · 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 |
|---|---|---|---|
| * | DEN130023 | Urolift System Our reading of the summary gave K130651, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130023, Urolift System (Neotract, Inc.), granted Sep 13, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2013 |
What descends from it? (9)
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?
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 | — |
What is it indicated for?
UroLift System is intended for the 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 as stated in the FDA summary.
https://510kreport.com/device/K133281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133281: Neotract Urolift System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133281
Report an extraction error
Are you the manufacturer?
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