Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gostar Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024-11-20 | 147 | 0 |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | 2023-12-19 | 459 | 0 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023-01-20 | 249 | 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