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

Biomedical Enterprises, Inc. — Predicate Candidate Screening

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

111 daysmedian FDA review time

377 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153573	Converge	Biomedical Enterprises, Inc.	2016-08-11	240	0
K150125	Elite Nitinol Fixation System	Biomedical Enterprises, Inc.	2015-05-11	111	0
K143023	Nitinol Compression Plating System	Biomedical Enterprises, Inc.	2015-01-16	87	0
K142292	Speed, Speed Shift, Speed Titan, Speed Arc	Biomedical Enterprises, Inc.	2014-11-17	91	3
K133270	SPEED ARC	Biomedical Enterprises, Inc.	2014-04-17	176	0
K133520	HAMMERLOCK 2	Biomedical Enterprises, Inc.	2014-01-09	55	0
K124022	SPEED SHIFT	Biomedical Enterprises, Inc.	2013-05-14	137	0
K061385	OSSTAPLE, OSSPLATE, OSSFORCE	Biomedical Enterprises, Inc.	2007-05-30	377	0
K023486	OSSTAPLE, MAXILLOFACIAL	Biomedical Enterprises, Inc.	2002-10-31	14	0
K023488	OSSTAPLE, CRANIOFACIAL	Biomedical Enterprises, Inc.	2002-10-31	14	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