Atlas FDA

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

Ucp Biosciences, Inc. · Predicate Candidate Screening

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

94 daysmedian FDA review time
215 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152908UCP COMPACT DRUG TESTSUcp Biosciences, Inc.2016-05-032150
K151213UCP Drug Test Mini CupsUcp Biosciences, Inc.2015-08-211070
K132812UCP MULTI-DRUG TEST KEY CUPSUcp Biosciences, Inc.2014-03-061780
K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY Ucp Biosciences, Inc.2013-11-071900
K131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSUcp Biosciences, Inc.2013-07-19300
K130463UCP HOME DRUG SCREENING TEST; CARDS, CUPSUcp Biosciences, Inc.2013-05-15820
K123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSUcp Biosciences, Inc.2013-01-09260
K122419UCP HOME DRUG SCREENING TEST CUPSUcp Biosciences, Inc.2012-11-301130
K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.2011-04-20560
K091612UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, CUcp Biosciences, Inc.2010-02-242660
K091588UCP HOME DRUG SCREENING TESTSUcp Biosciences, Inc.2009-09-04940
K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.2007-09-20550
K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHUcp Biosciences, Inc.2006-08-21880
K050540UCP RAPID DRUG SCREENING TESTSUcp Biosciences, Inc.2005-04-29580

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