Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ding Hwa Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
158 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | 2018-07-23 | 55 | 0 |
| K140809 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2014-06-23 | 83 | 0 |
| K140031 | SUCTION PUMP | Ding Hwa Co., Ltd. | 2014-04-28 | 112 | 0 |
| K132308 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2013-12-30 | 158 | 0 |
| K080005 | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | Ding Hwa Co., Ltd. | 2008-04-24 | 113 | 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