# K133281: Neotract Urolift System

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Dec 20, 2013 after 56 days
- Product code: PEW (Implantable Transprostatic Tissue Retractor System)
- Device class: 2
- Regulation: 21 CFR 876.5530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130023 (2013). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130023: Urolift System, Neotract, Inc. (2013). 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.

## Most influential descendants
- K153584: NeoTract UroLift System UL500 (2016), 8 descendants of its own
- K162345: UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (2016), 7 descendants of its own
- K172359: UroLift System (UL500) (2017), 6 descendants of its own
- K173087: UroLift System (UL400 and UL500) (2017), 5 descendants of its own
- K201837: UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (2020), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K133281
Methodology: https://510kreport.com/methodology