Hangzhou Qiantang Longyue Biotechnology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hangzhou Qiantang Longyue Biotechnology Co., Ltd.” (first 2023, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 199 days. Since 2017 the median was 199 days, against 172 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 |
|---|---|---|
| 2023 | 1 | 183 |
| 2024 | 3 | 224 |
| 2025 | 0 | — |
| 2026 | 2 | 133 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hangzhou Qiantang Longyue Biotechnology Co., Ltd. took a median 199 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Hangzhou Qiantang Longyue Biotechnology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | FMI | 2026-08-07 | 140 |
| K260301 | Vial Adapter | LHI | 2026-06-05 | 126 |
| K233287 | Vent Vial Adapter | LHI | 2024-07-26 | 301 |
| K233277 | Filter Needle for Single Use | FPB | 2024-05-10 | 224 |
| K233284 | Vial Adapter with Filter | LHI | 2024-05-01 | 215 |
| K222718 | Vial Adapter | LHI | 2023-03-10 | 183 |
Recalls
openFDA lists no recalls under a recalling firm named Hangzhou Qiantang Longyue Biotechnology 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hangzhou AGS MedTech Co., Ltd. (19 510(k)s)
- Hangzhou AllTest Biotech Co., Ltd. (14 510(k)s)
- Hangzhou Hua'An Medical & Health Instruments Co., (10 510(k)s)
- Hangzhou Clongene Biotech Co., Ltd. (9 510(k)s)
- Hangzhou SHINING3D Dental Technology Co., Ltd. (5 510(k)s)
- Hangzhou Bever Medical Devices Co., Ltd. (4 510(k)s)
- Hangzhou Jimushi Meditech Co., Ltd. (3 510(k)s)
- Hangzhou Kangji Medical Instrument Co., Ltd. (3 510(k)s)
- Hangzhou Laihe Biotech Co., Ltd. (3 510(k)s)
- Hangzhou Tappa Medical Technology Co., Ltd. (3 510(k)s)
- Hangzhou Primecare Medical Co., Ltd. (2 510(k)s)
- Hangzhou Runheng Medical Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hangzhou Qiantang Longyue Biotechnology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Hangzhou Qiantang Longyue Biotechnology Co., Ltd.” (first 2023, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hangzhou Qiantang Longyue Biotechnology Co., Ltd. is 199 days. Since 2017: 199 days, versus 172 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hangzhou Qiantang Longyue Biotechnology Co., Ltd.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 4); FMI (Needle, Hypodermic, Single Lumen, 1); FPB (Filter, Infusion Line, 1).
Next steps
- See all 6 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Hangzhou Qiantang Longyue Biotechnology 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.