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

Biomedics · Predicate Candidate Screening

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

88 daysmedian FDA review time

272 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K992330	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMA	Biomedics	1999-11-23	134
K984583	THE BIOPLATE SHUNT CONNECTOR	Biomedics	1999-03-15	81
K980983	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMA	Biomedics	1998-06-09	84
K972463	THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMA	Biomedics	1997-09-25	86
K961976	THE BIOPLATE FIXATION SYSTEM	Biomedics	1996-08-16	88
K953273	BIOPLATE RIGID FIXATION BONE PLATING SYSTEM	Biomedics	1995-09-29	78
K943071	THE TITANIUM FIXATION SYSTEM	Biomedics	1995-01-06	192
K844787	BIOMETRIC TOTAL HIP SYSTEM	Biomedics	1985-04-19	130
K842687	BIOMEDICS BLADDER SCANNER	Biomedics	1985-04-08	272
K801345	KAMPNER HINGED TOE PROSTHESIS	Biomedics	1980-07-08	32

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