Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
215 daysmedian FDA review time
301 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR- | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 | 140 | 0 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 | 126 | 0 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 | 301 | 0 |
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-10 | 224 | 0 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 | 215 | 0 |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023-03-10 | 183 | 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