Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotop Technology 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) |
|---|---|---|---|---|---|
| K062318 | BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1 | Biotop Technology Co., Ltd. | 2007-01-03 | 147 | 0 |
| K043038 | BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC | Biotop Technology Co., Ltd. | 2004-12-22 | 48 | 0 |
| K041970 | BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC | Biotop Technology Co., Ltd. | 2004-08-03 | 12 | 0 |
| K032747 | BIOTOP DJT-A SAFETY SYRINGE | Biotop Technology Co., Ltd. | 2004-05-11 | 250 | 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