Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bain Medical Equipment (Guangzhou) Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
373 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 | 287 | 0 |
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 | 158 | 0 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 | 200 | 0 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-03-10 | 246 | 0 |
| K203524 | Surgical Masks | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-02-25 | 86 | 0 |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-07-20 | 262 | 0 |
| K161582 | DORA Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-06-16 | 373 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda