Cleared Traditional

eCareManager 4.1 (K171322) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171322 · Visicu, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
90d
Days
Class 2
Risk

K171322 is an FDA 510(k) clearance for the eCareManager 4.1. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Visicu, Inc. (Baltimore, US). The FDA issued a Cleared decision on August 3, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Visicu, Inc. devices

Submission Details

510(k) Number K171322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2017
Decision Date August 03, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 45
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K171322.
Wearable Device
K182543 · Snap40, Ltd. · Nov 2018
Unite Connect for Clinical Systems
K180566 · Ascom (Sweden) AB · Apr 2018
Athena GTX Device Management Suite (ADMS) Software
K173203 · Athena Gtx · Mar 2018
BeneVision Central Monitoring System
K162607 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2017
Hypervisor IX Monitoring System
K150632 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2015
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
K080192 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2008