Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meta Systems Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025-10-14 | 7 | 0 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | 2022-09-21 | 581 | 0 |
| K210789 | EQ-PEX | Meta Systems Co., Ltd. | 2021-10-20 | 218 | 0 |
| K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016-08-12 | 274 | 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