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

Biomatlante — Predicate Candidate Screening

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

164 daysmedian FDA review time

250 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093122	MBCP+	Biomatlante	2010-03-15	164	0
K071121	TRIBONE 80	Biomatlante	2007-09-11	144	0
K063527	MBCP+	Biomatlante	2007-07-30	250	1
K060732	MBCP GEL	Biomatlante	2006-06-02	74	0
K051774	MBCP	Biomatlante	2006-01-20	203	0
K051885	MBCP	Biomatlante	2005-09-16	66	0
K043005	MODIFICATION TO MBCP	Biomatlante	2005-05-03	183	0
K032268	MBCP	Biomatlante	2003-12-11	141	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