Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mtre Advanced Technology , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
235 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102112 | CRITICOOL PRO | Mtre Advanced Technology , Ltd. | 2010-11-18 | 113 | 0 |
| K083662 | CRITICOOL | Mtre Advanced Technology , Ltd. | 2009-03-26 | 106 | 1 |
| K024128 | ALLON 2001 VERSION 5 | Mtre Advanced Technology , Ltd. | 2003-02-10 | 56 | 1 |
| K003349 | ALLON 2001 MODIFIED | Mtre Advanced Technology , Ltd. | 2000-11-13 | 18 | 0 |
| K001546 | ALLON 2001 | Mtre Advanced Technology , Ltd. | 2000-06-08 | 21 | 0 |
| K992386 | ALLON 2000 | Mtre Advanced Technology , Ltd. | 2000-03-07 | 235 | 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