Cleared Traditional

K151839 - AMC Health VitalCaregiving System (FDA 510(k) Clearance)

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

K151839 · Amc Health · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
431d
Days
Class 2
Risk

K151839 is an FDA 510(k) clearance for the AMC Health VitalCaregiving System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Amc Health (New York, US). The FDA issued a Cleared decision on September 9, 2016 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Amc Health devices

Submission Details

510(k) Number K151839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2015
Decision Date September 09, 2016
Days to Decision 431 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
306d slower than avg
Panel avg: 125d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 304
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K151839.
c-med0 alpha
K253436 · Cosinuss GmbH · Apr 2026
WAVE Clinical Platform (2.0.000)
K250135 · Baxter Healthcare Corp/ Excel Medical · Jan 2026
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · Fysicon BV · Aug 2025
Empatica Health Monitoring Platform
K242737 · Empatica S.R.L. · Jun 2025
WARD-CSS (v1.2.x)
K241958 · Ward 24/7 Aps · Feb 2025
iCare APP
K243146 · Ihealth Labs, Inc. · Feb 2025