Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Manteia Technologies Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
269 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | 2026-01-23 | 268 | 0 |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | 2025-12-05 | 266 | 0 |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025-10-24 | 231 | 0 |
| K223834 | AccuCheck | Manteia Technologies Co., Ltd. | 2023-07-20 | 210 | 0 |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | 2023-07-10 | 209 | 0 |
| K221706 | AccuContour | Manteia Technologies Co., Ltd. | 2023-03-09 | 269 | 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