Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Branan Medical Corporation · Predicate Candidate Screening

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

118 daysmedian FDA review time
125 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103227ORATECT ORAL FLUID DRUG SCREEN DEVICESBranan Medical Corporation2012-04-115270
K082508FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCBranan Medical Corporation2008-11-21840
K002264BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TESTBranan Medical Corporation2000-11-271250
K002265BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCRBranan Medical Corporation2000-11-271250
K002268BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEBranan Medical Corporation2000-11-271250
K002342BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TESTBranan Medical Corporation2000-11-271180
K002266BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN Branan Medical Corporation2000-11-221200
K002337BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREENBranan Medical Corporation2000-11-221130
K002417BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEBranan Medical Corporation2000-11-221060
K002418BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREENBranan Medical Corporation2000-11-221060
K002587BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUGBranan Medical Corporation2000-11-22930

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