510(k) Report

FDA applicant

Neotract, Inc.

Pleasanton, CA17 decisions2006–20232 recalls

FDA records 17 decisions for Neotract, Inc. (Pleasanton, CA) from 2006 to 2023: 16 510(k) clearances and 1 De Novo grant. Most are in product codes PEW (Implantable Transprostatic Tissue Retractor…) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 20 predicates, 16 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Neotract, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12010: 22013: 22016: 22017: 22019: 22020: 32021: 12023: 1
2007high 3 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2018: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Neotract, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neotract, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PEWImplantable Transprostatic Tissue Retractor System11decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene3decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision

Whose devices does it build on?

Its devices cite 20 predicates; 16 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173087UroLift System (UL400 and UL500)Neotract, Inc. · 20173cite it
  • DEN130023Urolift SystemNeotract, Inc. · 20132cite it
  • K133281Neotract Urolift SystemNeotract, Inc. · 20132cite it
  • K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 20201cites it
  • K193269UroLift System (UL400)Neotract, Inc. · 20191cites it
  • K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc. · 20161cites it

What has FDA decided for it lately?

  • K232558UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. · 2023
  • K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc. · 2021
  • K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeNeotract, Inc. · 2020
  • K200441UroLift Advanced Tissue Control (ATC) SystemNeotract, Inc. · 2020
  • K192781UroLift System Procedure Kit Sterilization TrayNeotract, Inc. · 2020
  • K193269UroLift System (UL400)Neotract, Inc. · 20191 recall
  • K190377UroLift System UL400Neotract, Inc. · 2019
  • K173087UroLift System (UL400 and UL500)Neotract, Inc. · 20171 recall

All 17 as Neotract, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K193269UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release ToolJun 24, 2022Class II
  • K173087UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle…Jul 6, 2018Class II