510(k) · Cleared
ClearedUroLift System UL400
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 Mar 21, 2019 as substantially equivalent to K173087 (Neotract, Inc., 2017) after a 30-day review. Its family tree reaches back 6 generations to 2013.
- Decided
- Mar 21, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- PEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN130023 (2013). No later device cites it as a predicate yet.
- Root · 6 generations backDEN130023 Urolift SystemNeotract, Inc. · 2013
- 5 generations backK133281 Neotract Urolift SystemNeotract, Inc. · 2013
- 4 generations backK153584 NeoTract UroLift System UL500Neotract, Inc. · 2016
- 3 generations backK162345 UroLift System UL500, UroLift Delivery Handle, UroLift Implant…Neotract, Inc. · 2016
- 2 generations backK172359 UroLift System (UL500)Neotract, Inc. · 2017
- 1 generation backK173087 UroLift System (UL400 and UL500)Neotract, Inc. · 2017 · Recalled
- This deviceK190377 UroLift System UL400Neotract, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN130023 | Urolift System | Neotract, Inc. | 2013 | — |
| −5 | K133281 | Neotract Urolift System | Neotract, Inc. | 2013 | — |
| −4 | K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016 | — |
| −3 | K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | Neotract, Inc. | 2016 | — |
| −2 | K172359 | UroLift System (UL500) | Neotract, Inc. | 2017 | — |
| −1 | K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017 | 1 |
| 0 (this device) | K190377 | UroLift System UL400 | Neotract, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K173087 | UroLift System (UL400 and UL500)Summary page 4…tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UL400 (most recently cleared in K173087), consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per deliv… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K173087.
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. 2019, 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 as stated in the FDA summary.
https://510kreport.com/device/K190377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190377: UroLift System UL400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190377
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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