510(k) · Cleared
Recalled · Class II · 2018UroLift System (UL400 and UL500)
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 28, 2017 as substantially equivalent to K133281 (Neotract, Inc., 2013) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2013. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 28, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- PEW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN130023 (2013). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backDEN130023 Urolift SystemNeotract, Inc. · 2013
- 4 generations backK133281 Neotract Urolift SystemNeotract, Inc. · 2013
- 3 generations backK153584 NeoTract UroLift System UL500Neotract, Inc. · 2016
- 2 generations backK162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant…Neotract, Inc. · 2016
- 1 generation backK172359 UroLift System (UL500)Neotract, Inc. · 2017
- This deviceK173087 UroLift System (UL400 and UL500)Neotract, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK201837 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle…Neotract, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK193269 UroLift System (UL400)Neotract, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK232558 UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK200441 UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190377 UroLift System UL400Neotract, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc. · 2020 · cites it directly1descendant
- K193269UroLift System (UL400)Neotract, Inc. · 2019 · cites it directly1descendant
- K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. · 2023 · 2 generations on0descendants
- K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc. · 2020 · 2 generations on0descendants
- K190377UroLift System UL400Neotract, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN130023 | Urolift System | Neotract, Inc. | 2013 | — |
| −4 | K133281 | Neotract Urolift System | Neotract, Inc. | 2013 | — |
| −3 | K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016 | — |
| −2 | K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016 | — |
| −1 | K172359 | UroLift System (UL500) | Neotract, Inc. | 2017 | — |
| 0 (this device) | K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017 | — |
| +1 | K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2… | Neotract, Inc. | 2020 | — |
| +1 | K193269 | UroLift System (UL400) | Neotract, Inc. | 2019 | 1 |
| +2 | K232558 | UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. | 2023 | — |
| +2 | K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. | 2020 | — |
| +1 | K190377 | UroLift System UL400 | Neotract, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K133281 | Neotract Urolift SystemSummary page 4…REDICATE DEVICE The predicate device is the UroLift System, which includes two generations of the device, the UL400 and the UL500. The UL400 was previously cleared under K133281. The UL500 was previously cleared under K172359. DEVICE DESCRIPTION The UroLift System is designed to access the prostatic ureth… | 2013 |
| * | K172359 | UroLift System (UL500)Summary page 4…ift System, which includes two generations of the device, the UL400 and the UL500. The UL400 was previously cleared under K133281. The UL500 was previously cleared under K172359. DEVICE DESCRIPTION The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lob… | 2017 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2018 | Class II | Z-0598-2019 | Finished device change control | Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201837 (Neotract, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K133281.
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. 2017, 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?
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 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/K173087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173087: UroLift System (UL400 and UL500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173087
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