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

Branan Medical Corp. · Predicate Candidate Screening

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

70 daysmedian FDA review time

162 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122633	TOXCUP DRUG SCREEN CUP	Branan Medical Corp.	2013-02-07	162	0
K122752	FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN	Branan Medical Corp.	2013-01-30	145	0
K040203	MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT	Branan Medical Corp.	2004-03-25	56	0
K032057	TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC	Branan Medical Corp.	2003-08-21	50	1
K030113	MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, F	Branan Medical Corp.	2003-07-02	170	0
K023489	QUICKTOX MULTIPLE DRUG DIPCARD	Branan Medical Corp.	2002-12-16	60	0
K022355	QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/M	Branan Medical Corp.	2002-07-30	11	1
K013124	MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP	Branan Medical Corp.	2001-11-07	49	0
K012541	MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FA	Branan Medical Corp.	2001-09-04	28	0
K010734	BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MO	Branan Medical Corp.	2001-07-30	140	0
K004034	MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC	Branan Medical Corp.	2001-03-08	70	0
K002263	BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST	Branan Medical Corp.	2000-11-27	125	0
K002272	BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MO	Branan Medical Corp.	2000-11-22	119	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