Neotract, Inc.: FDA clearances and approvals
Neotract, Inc. has 16 FDA 510(k) clearances (first 2006, latest 2023), plus 1 De Novo decision, across 4 product codes in 3 review panels. Median 510(k) review time: 46 days. Since 2017 its median was 30 days, against 132 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Neotract, Inc. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 56 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 60 |
| 2017 | 2 | 52 |
| 2018 | 0 | — |
| 2019 | 2 | 27 |
| 2020 | 3 | 102 |
| 2021 | 1 | 81 |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Neotract, Inc.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PEW | Implantable Transprostatic Tissue Retractor System | 11 | 10 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Neotract, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232558 | UroLift 2 ATC Advanced Tissue Control System | PEW | 2023-09-22 | 30 |
| K212396 | UroLift System Rigid Retrieval Kit Sterilization Tray | KCT | 2021-10-22 | 81 |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | PEW | 2020-07-31 | 29 |
| K200441 | UroLift Advanced Tissue Control (ATC) System | PEW | 2020-06-05 | 102 |
| K192781 | UroLift System Procedure Kit Sterilization Tray | KCT | 2020-04-14 | 197 |
| K193269 | UroLift System (UL400) | PEW | 2019-12-20 | 24 |
| K190377 | UroLift System UL400 | PEW | 2019-03-21 | 30 |
| K173087 | UroLift System (UL400 and UL500) | PEW | 2017-12-28 | 90 |
| K172359 | UroLift System (UL500) | PEW | 2017-08-18 | 14 |
| K162345 | UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge | PEW | 2016-09-21 | 30 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130023 | De Novo | Implantable Transprostatic Tissue Retractor System | 2013-09-13 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2022-06-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Neotract, Inc. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04338776: Comparing UroLift Experience Against Rezūm (Active not recruiting, started 2021-01-22)
- NCT04271020: Urodynamic Feasibility Study Utilizing the UroLift® System (Completed, started 2018-10-25)
- NCT03194737: Prostatic Urethral Lift in Subject With Acute Urinary Retention (Completed, started 2018-03-24)
- NCT02625545: Study of Median Lobe Prostatic UroLift Procedure (Completed, started 2016-02-17)
- NCT01876706: UroLift System TOlerability and ReCovery When Administering Local Anesthesia (Completed, started 2013-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Neotract, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Neotract, Inc. have?
Neotract, Inc. has 16 FDA 510(k) clearances (first 2006, latest 2023), plus 1 De Novo decision, across 4 product codes in 3 review panels.
How long does FDA take to clear Neotract, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Neotract, Inc.'s cleared 510(k)s is 46 days. Since 2017: 30 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Neotract, Inc. make?
Its most frequent FDA product codes are PEW (Implantable Transprostatic Tissue Retractor System, 11); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2).
Has Neotract, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Neotract, Inc; the most recent began 2022-06-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 16 Neotract, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PEW, Neotract, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.