Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qingdao Hightop Biotech 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) |
|---|---|---|---|---|---|
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Pane | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 | 40 | 0 |
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine | Qingdao Hightop Biotech Co., Ltd. | 2022-05-05 | 58 | 0 |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rap | Qingdao Hightop Biotech Co., Ltd. | 2019-09-05 | 30 | 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