Foshan Nanhai Plus Medical Co, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Foshan Nanhai Plus Medical Co, Ltd.” (first 2015, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 207 days. Since 2017 the median was 186 days, against 153 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 |
|---|---|---|
| 2015 | 2 | 632 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 184 |
| 2022 | 5 | 189 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Foshan Nanhai Plus Medical Co, Ltd. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 5 | 5 |
| FXX | Mask, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Foshan Nanhai Plus Medical Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | FYA | 2022-11-14 | 89 |
| K213177 | Plus Medical Cover Gown | FYA | 2022-05-11 | 225 |
| K211036 | Plus Medical Chemotherapy Gown | FYA | 2022-05-04 | 392 |
| K212698 | Plus Medical Isolation Gown Level 3 | FYC | 2022-03-02 | 189 |
| K212610 | Surgical Face Mask | FXX | 2022-01-26 | 162 |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | FYA | 2021-07-22 | 184 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | KKX | 2015-06-24 | 632 |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | FYA | 2015-06-24 | 632 |
Recalls
openFDA lists no recalls under a recalling firm named Foshan Nanhai Plus 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.
- Foshan Coxo Medical Instrument Co., Ltd. (7 510(k)s)
- Foshan Gaunying Electronics Co., Ltd. (6 510(k)s)
- Foshan Care Medical Technology Co., Ltd. (4 510(k)s)
- Foshan Cicada Dental Instrument Co, Ltd. (4 510(k)s)
- Foshan Dahao Medical Technology Co., Ltd. (3 510(k)s)
- Foshan Pingchuang Medical Technology Co., Ltd. (3 510(k)s)
- Foshan United Medical Technologies, Ltd. (3 510(k)s)
- Foshan Hongfeng Co., Ltd. (2 510(k)s)
- Foshan Jindi Electric Appliance Co., Ltd. (2 510(k)s)
- Foshan Kycare Medical Equipment Co., Ltd. (2 510(k)s)
- Foshan Nanhai Bai HE Medical Technology Co., Ltd. (2 510(k)s)
- Foshan Topmed Dental Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Foshan Nanhai Plus Medical Co, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Foshan Nanhai Plus Medical Co, Ltd.” (first 2015, latest 2022), 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 Foshan Nanhai Plus Medical Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foshan Nanhai Plus Medical Co, Ltd. is 207 days. Since 2017: 186 days, versus 153 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Foshan Nanhai Plus Medical Co, Ltd.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 5); FXX (Mask, Surgical, 1); FYC (Gown, Isolation, Surgical, 1).
Next steps
- See all 8 Foshan Nanhai Plus Medical Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Foshan Nanhai Plus 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.