Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sichuan Prius Biotechnology Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
223 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needle | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needl | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K221080 | Sterile Safety Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K221066 | Sterile Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K210908 | Surgical Mask | Sichuan Prius Biotechnology Co., Ltd. | 2021-09-26 | 181 | 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