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

Medicotest A/S — Predicate Candidate Screening

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

87 daysmedian FDA review time

227 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K020382	BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA	Medicotest A/S	2002-06-28	143
K020907	NEUROLINE, SUBDERMAL NEEDLE ELECTRODES	Medicotest A/S	2002-06-14	86
K002079	MULTI-FUNCTION DEFIBRILLATION ELECTRODE	Medicotest A/S	2001-02-22	227
K001869	DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYP	Medicotest A/S	2000-09-18	90
K983689	BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES	Medicotest A/S	1999-01-15	87
K973529	NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES	Medicotest A/S	1997-11-20	63
K965194	MEDICOM, TENS ELECTRODES	Medicotest A/S	1997-03-06	72

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