Mtre Advanced Technology , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mtre Advanced Technology , Ltd.” (first 2000, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 81 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Mtre Advanced Technology , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102112 | CRITICOOL PRO | DWJ | 2010-11-18 | 113 |
| K083662 | CRITICOOL | DWJ | 2009-03-26 | 106 |
| K024128 | ALLON 2001 VERSION 5 | DWJ | 2003-02-10 | 56 |
| K003349 | ALLON 2001 MODIFIED | DWJ | 2000-11-13 | 18 |
| K001546 | ALLON 2001 | DWJ | 2000-06-08 | 21 |
| K992386 | ALLON 2000 | DWJ | 2000-03-07 | 235 |
Recalls
openFDA lists no recalls under a recalling firm named Mtre Advanced Technology , 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mtre Advanced Technology , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Mtre Advanced Technology , Ltd.” (first 2000, latest 2010), 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 Mtre Advanced Technology , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mtre Advanced Technology , Ltd. is 81 days.
Which FDA product codes appear under Mtre Advanced Technology , Ltd.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 6).
Next steps
- See all 6 Mtre Advanced Technology , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Mtre Advanced Technology , 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.