Atlas FDA

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

EXR · Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

34 daysmedian FDA review time
337 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934142URINARY DRAINAGE BAGKey Medical Services, Inc.1994-05-172650
K935578URINE METERPuritas Health Care, Inc.1993-12-17290
K911258KENDALL PEDIATRIC URINE METERKendall Healthcare Products Co. Div.Of Tyco Health1991-04-25340
K896732UNOMETER 500Unoplast A/S1990-11-023370
K870240COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.1987-02-20300
K771561DOVER URINE METERWill Ross Co.1977-09-07230
K770423URINE TESTER, MODEL NO. 707Brother Scientific Products, Inc.1977-06-03880
K770939URINE TESTER, MODEL 701Brother Scientific Products, Inc.1977-06-03110
K761083BARD URINE METER W/ BAGC.R. Bard, Inc.1977-01-26680

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