Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Maersk Medical A/S · Predicate Candidate Screening

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

327 daysmedian FDA review time

327 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K011071	PARADIGM QUICK-SET INFUSION SET	Maersk Medical A/S	2001-06-07	59	2
K002138	PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380	Maersk Medical A/S	2000-08-29	43	1
K990110	DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140	Maersk Medical A/S	1999-12-06	327	0
K990111	DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 457	Maersk Medical A/S	1999-12-06	327	0
K990112	DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610	Maersk Medical A/S	1999-12-06	327	0
K990113	DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533	Maersk Medical A/S	1999-12-06	327	1
K990115	DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440	Maersk Medical A/S	1999-12-06	327	0
K991759	MAERSK MEDICAL CONTOUR INFUSION SET	Maersk Medical A/S	1999-06-25	32	0
K973364	4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY	Maersk Medical A/S	1998-03-17	190	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