Shanghai Sanyou Medical Co, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Shanghai Sanyou Medical Co, Ltd.” (first 2013, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 140 days. Since 2017 the median was 188 days, against 89 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 |
|---|---|---|
| 2013 | 1 | 71 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 140 |
| 2017 | 2 | 298 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 78 |
| 2022 | 0 | — |
| 2023 | 3 | 188 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shanghai Sanyou Medical Co, Ltd. took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Shanghai Sanyou Medical Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | MAX | 2023-12-12 | 257 |
| K230961 | Zeus Spinal System | NKB | 2023-10-10 | 188 |
| K231931 | Adena-Zina Spinal System | NKB | 2023-07-28 | 28 |
| K211689 | KEYSTONE PEEK Cage System | MAX | 2021-09-21 | 111 |
| K212066 | Adena-Zina System | NKB | 2021-08-16 | 45 |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | KWQ | 2017-10-05 | 309 |
| K163422 | Shanghai Sanyou PEEK Cage System | ODP | 2017-09-18 | 286 |
| K152781 | Adena-Zina System | NKB | 2016-02-12 | 140 |
| K131512 | KATIA SYSTEM | KWQ | 2013-08-07 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai Sanyou Medical 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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai Sanyou Medical Co, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Shanghai Sanyou Medical Co, Ltd.” (first 2013, latest 2023), across 4 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 Shanghai Sanyou Medical Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Sanyou Medical Co, Ltd. is 140 days. Since 2017: 188 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanghai Sanyou Medical Co, Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 9 Shanghai Sanyou Medical Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Shanghai Sanyou Medical 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.