Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bio D Corp. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

45 daysmedian FDA review time
45 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802732URINE COLLECTION BAG TYPE AP2132VBio D Corp.1980-12-18450
K802737URINE COLLECTION BAG TYPE 1590VBio D Corp.1980-12-18450
K802733URINE COLLECTION BAG TYPE AP2090VBio D Corp.1980-12-18450
K802729URINE COLLECTION BAG TYPE 2132VBio D Corp.1980-12-18450
K802736URINE COOLECTION BAG TYPE 2090VBio D Corp.1980-12-18450
K802735URINE COLLECTION BAG TYPE 740APBio D Corp.1980-12-18450
K802739URINE COLLECTION BAG TYPE 710APBio D Corp.1980-12-18450
K802734URINE COLLECTION BAG TYPE 710Bio D Corp.1980-12-18450
K802738URINE COLLECTION BAG TYPE 1505VBio D Corp.1980-12-18450
K802740FLUFF UNDERPAD TYPE UP1001Bio D Corp.1980-12-10370
K802730FLUFF UNDERPAD TYPE UP1002Bio D Corp.1980-12-10370

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