Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ningbo Diaier Electronic Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123839 | WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 | Ningbo Diaier Electronic Co., Ltd. | 2013-01-11 | 29 | 0 |
| K093739 | BLOOD PRESSURE MONITOR/ MODELS | Ningbo Diaier Electronic Co., Ltd. | 2010-05-07 | 154 | 0 |
| K091553 | BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL | Ningbo Diaier Electronic Co., Ltd. | 2009-09-21 | 117 | 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