Medi-Tate , Ltd.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Medi-Tate , Ltd.” (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 157 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 157 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medi-Tate , Ltd. took a median 157 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | 2 | 1 |
Review panels
Most recent Medi-Tate , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210138 | iTind System | QKA | 2021-06-25 | 157 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190020 | De Novo | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | 2020-02-25 |
Recalls
openFDA lists no recalls under a recalling firm named Medi-Tate , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medi-Tate , Ltd. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02506465: Pivotal Study to Assess the Safety and Effectiveness of the iTind Device (Completed, started 2015-07)
- NCT02145208: Study to Assess the Efficacy of Medi-Tate iTind Device (Completed, started 2014-10)
- NCT01436877: Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia (Completed, started 2011-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medi-Tate , Ltd.?
FDA lists 1 510(k) clearance under the applicant name “Medi-Tate , Ltd.” (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medi-Tate , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Tate , Ltd. is 157 days.
Which FDA product codes appear under Medi-Tate , Ltd.?
The most frequent FDA product codes under this applicant name are QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia, 2).
Next steps
- See all 1 Medi-Tate , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QKA, Medi-Tate , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.