Sichuan Prius Biotechnology Co., Ltd.: FDA clearances and approvals
Sichuan Prius Biotechnology Co., Ltd. has 9 FDA 510(k) clearances (first 2021, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time: 175 days. Since 2017 its median was 175 days, against 162 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 181 |
| 2022 | 8 | 175 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sichuan Prius Biotechnology Co., Ltd.'s cleared 510(k)s took a median 175 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
- General Hospital (9)
Most recent Sichuan Prius Biotechnology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | FPA | 2022-11-21 | 223 |
| K221075 | Infusion Sets for Single Use | FPA | 2022-11-21 | 223 |
| K221069 | Infusion Sets for Single Use with Needles | FPA | 2022-11-21 | 223 |
| K221080 | Sterile Safety Hypodermic Needles for Single Use | FMI | 2022-10-04 | 175 |
| K221079 | Sterile Hypodermic Syringes for Single Use | FMF | 2022-10-04 | 175 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | MEG | 2022-10-04 | 175 |
| K221068 | Sterile Hypodermic Syringes for Single Use with Needles | FMF | 2022-10-04 | 175 |
| K221066 | Sterile Hypodermic Needles for Single Use | FMI | 2022-10-04 | 175 |
| K210908 | Surgical Mask | FXX | 2021-09-26 | 181 |
Recalls
openFDA lists no recalls under a recalling firm named Sichuan Prius Biotechnology Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sichuan Prius Biotechnology Co., Ltd. have?
Sichuan Prius Biotechnology Co., Ltd. has 9 FDA 510(k) clearances (first 2021, latest 2022), across 5 product codes in 1 review panel.
How long does FDA take to clear Sichuan Prius Biotechnology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Sichuan Prius Biotechnology Co., Ltd.'s cleared 510(k)s is 175 days. Since 2017: 175 days, versus 162 days for all cleared 510(k)s in the same product codes.
What devices does Sichuan Prius Biotechnology Co., Ltd. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 3); FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 2).
Has Sichuan Prius Biotechnology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sichuan Prius Biotechnology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Sichuan Prius Biotechnology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Sichuan Prius Biotechnology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.