Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Benq Materials Corporation — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color | Benq Materials Corporation | 2025-04-17 | 276 | 0 |
| K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | Benq Materials Corporation | 2020-05-04 | 168 | 0 |
| K150963 | AnsCare ChitoClot Pad | Benq Materials Corporation | 2015-11-05 | 209 | 0 |
| K143462 | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClo | Benq Materials Corporation | 2015-05-08 | 155 | 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