Bain Medical Equipment (Guangzhou) Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bain Medical Equipment (Guangzhou) Co., Ltd.” (first 2017, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 246 days. Since 2017 the median was 246 days, against 146 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 |
|---|---|---|
| 2017 | 2 | 318 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 166 |
| 2022 | 1 | 200 |
| 2023 | 0 | — |
| 2024 | 1 | 158 |
| 2025 | 0 | — |
| 2026 | 1 | 287 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bain Medical Equipment (Guangzhou) Co., Ltd. took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 3 | 3 |
| FIE | Needle, Fistula | 2 | 2 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
Review panels
Most recent Bain Medical Equipment (Guangzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | FJK | 2026-05-15 | 287 |
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | FIB | 2024-06-28 | 158 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | FIE | 2022-04-08 | 200 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | FJK | 2021-03-10 | 246 |
| K203524 | Surgical Masks | FXX | 2021-02-25 | 86 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | FIE | 2017-07-20 | 262 |
| K161582 | DORA Tubing Sets for Hemodialysis | FJK | 2017-06-16 | 373 |
Recalls
openFDA lists no recalls under a recalling firm named Bain Medical Equipment (Guangzhou) 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 Bain Medical Equipment (Guangzhou) Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Bain Medical Equipment (Guangzhou) Co., Ltd.” (first 2017, latest 2026), across 4 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 Bain Medical Equipment (Guangzhou) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bain Medical Equipment (Guangzhou) Co., Ltd. is 246 days. Since 2017: 246 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bain Medical Equipment (Guangzhou) Co., Ltd.?
The most frequent FDA product codes under this applicant name are FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 3); FIE (Needle, Fistula, 2); FIB (Protector, Transducer, Dialysis, 1).
Next steps
- See all 7 Bain Medical Equipment (Guangzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FJK, Bain Medical Equipment (Guangzhou) 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.