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

Biometer Intl. A/S — Predicate Candidate Screening

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

151 daysmedian FDA review time

452 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K925159	TOF-GUARD TRANSMISSION MONITOR	Biometer Intl. A/S	1993-09-01	323
K914231	ELPHA 2000	Biometer Intl. A/S	1992-05-28	251
K892396	MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR	Biometer Intl. A/S	1989-10-03	179
K893485	ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR	Biometer Intl. A/S	1989-07-28	85
K890746	MYOTEST DBS NERVE STIMULATOR	Biometer Intl. A/S	1989-07-14	151
K881196	AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL	Biometer Intl. A/S	1989-06-16	452
K870619	ACCELOGRAPH	Biometer Intl. A/S	1987-03-16	32
K860187	MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING	Biometer Intl. A/S	1986-03-20	57
K860186	MYOTEST - NERVE STIMULATOR	Biometer Intl. A/S	1986-03-20	57

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