Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bq Plus Medical 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) |
|---|---|---|---|---|---|
| K242126 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2024-08-22 | 34 | 1 |
| K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | 2023-05-18 | 163 | 0 |
| K210381 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2021-08-14 | 186 | 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