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

Biomedical Ent., Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time

319 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K133844	SPEED TRIAD	Biomedical Ent., Inc.	2014-04-07	110
K133780	SPEED XL	Biomedical Ent., Inc.	2014-03-19	97
K131640	SMOOTH OR THREADED METALLIC BONE FASTENER	Biomedical Ent., Inc.	2013-10-16	134
K102107	OSSTAPLE CHILL	Biomedical Ent., Inc.	2010-09-03	38
K091951	HAMMERLOCK	Biomedical Ent., Inc.	2010-02-19	233
K023203	OSSTAPLE	Biomedical Ent., Inc.	2002-10-17	22
K001353	MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FR	Biomedical Ent., Inc.	2001-03-13	319
K001354	MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRA	Biomedical Ent., Inc.	2001-03-13	319
K001219	MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR	Biomedical Ent., Inc.	2000-06-21	65
K993714	MEMOGRAPH STAPLE, WARM SYSTEM	Biomedical Ent., Inc.	2000-02-25	115
K971782	BONE AND MARROW COLLECTION SYSTEM KIT	Biomedical Ent., Inc.	1997-07-29	76
K964073	BME BONE DRILL BITS	Biomedical Ent., Inc.	1996-11-14	34
K961901	BONE & MARROW COLLECTION SYSTEM	Biomedical Ent., Inc.	1996-08-06	82

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