FDA applicant
Mtre Advanced Technology, Ltd.
FDA records 6 decisions for Mtre Advanced Technology, Ltd. (Mccordsville, IN) from 2000 to 2010: 6 510(k) clearances. All are in product code DWJ (System, Thermal Regulating). Its devices cite 3 predicates, 2 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
How often FDA has decided Mtre Advanced Technology, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Mtre Advanced Technology, Ltd.’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