Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Taiject Medical Device 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) |
|---|---|---|---|---|---|
| K042426 | TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-10 | Taiject Medical Device Co., Ltd. | 2004-09-22 | 14 | 0 |
| K031062 | TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 IN | Taiject Medical Device Co., Ltd. | 2003-05-02 | 29 | 0 |
| K023458 | TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) | Taiject Medical Device Co., Ltd. | 2002-11-07 | 23 | 0 |
| K022278 | TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) | Taiject Medical Device Co., Ltd. | 2002-09-12 | 59 | 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