Safecare Biotech (Hangzhou) Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Safecare Biotech (Hangzhou) Co., Ltd.” (first 2016, latest 2025), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 55 days. Since 2017 the median was 44 days, against 58 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 88 |
| 2017 | 0 | — |
| 2018 | 2 | 41 |
| 2019 | 1 | 29 |
| 2020 | 2 | 118 |
| 2021 | 1 | 209 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 34 |
| 2025 | 1 | 119 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Safecare Biotech (Hangzhou) Co., Ltd. took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 58 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 3 | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| NFW | Test, Cannabinoid, Over The Counter | 1 | 1 |
| NGG | Test, Methamphetamine, Over The Counter | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
Review panels
Most recent Safecare Biotech (Hangzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242767 | Safecare Urinary Tract Infection Test | JMT | 2025-01-10 | 119 |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | NGL | 2024-04-10 | 34 |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | NFT | 2021-03-24 | 209 |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | LCX | 2020-08-13 | 205 |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | NFT | 2020-05-27 | 30 |
| K191924 | SAFECARE® THC Urine Strip Test | NFW | 2019-08-16 | 29 |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | NGG | 2018-11-19 | 55 |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | NFT | 2018-08-20 | 27 |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | DIO | 2016-03-18 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Safecare Biotech (Hangzhou) Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Safecare Biotech (Hangzhou) Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Safecare Biotech (Hangzhou) Co., Ltd.” (first 2016, latest 2025), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Safecare Biotech (Hangzhou) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Safecare Biotech (Hangzhou) Co., Ltd. is 55 days. Since 2017: 44 days, versus 58 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Safecare Biotech (Hangzhou) Co., Ltd.?
The most frequent FDA product codes under this applicant name are NFT (Test, Amphetamine, Over The Counter, 3); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), 1).
Next steps
- See all 9 Safecare Biotech (Hangzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFT, Safecare Biotech (Hangzhou) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.