Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangdong Xinyu Electronic and Technology Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-11 | 250 | 0 |
| K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, | Guangdong Xinyu Electronic and Technology Co., Ltd. | 2025-02-03 | 245 | 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