Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PEW · Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
102 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control System | Neotract, Inc. | 2023-09-22 | 30 | 0 |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle | Neotract, Inc. | 2020-07-31 | 29 | 0 |
| K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. | 2020-06-05 | 102 | 0 |
| K193269 | UroLift System (UL400) | Neotract, Inc. | 2019-12-20 | 24 | 1 |
| K190377 | UroLift System UL400 | Neotract, Inc. | 2019-03-21 | 30 | 0 |
| K173087 | UroLift System (UL400 and UL500) | Neotract, Inc. | 2017-12-28 | 90 | 0 |
| K172359 | UroLift System (UL500) | Neotract, Inc. | 2017-08-18 | 14 | 0 |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Impla | Neotract, Inc. | 2016-09-21 | 30 | 0 |
| K153584 | NeoTract UroLift System UL500 | Neotract, Inc. | 2016-03-15 | 91 | 0 |
| K133281 | NEOTRACT UROLIFT SYSTEM | Neotract, Inc. | 2013-12-20 | 56 | 0 |
| DEN130023 | UROLIFT SYSTEM | Neotract, Inc. | 2013-09-13 | 190 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda