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

Visicu, Inc. — Predicate Candidate Screening

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

99 daysmedian FDA review time

421 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211046	eCareManager 4.5	Visicu, Inc.	2022-06-03	421	0
K171322	eCareManager 4.1	Visicu, Inc.	2017-08-03	90	0
K171029	eCareCoordinator	Visicu, Inc.	2017-07-14	99	0
K153156	eCareManager 4.0.1	Visicu, Inc.	2016-09-30	333	0
K141706	ECARE COORDINATOR (ECC)	Visicu, Inc.	2014-09-09	77	0
K012171	MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK	Visicu, Inc.	2001-07-24	12	2
K001972	ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK	Visicu, Inc.	2000-10-27	121	2

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