Cleared Traditional

AMC Health VitalCaregiving System (K151839) - 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
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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 112
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K151839.
Masimo Rad-97 and Accessories
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Unity Network ID
K170199 · Ge Healthcare · May 2017
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K160718 · Covidien · Nov 2016
Unity Network ID
K142840 · Ge Healthcare · Jan 2015
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · Welch Allyn, Inc. · Dec 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K140339 · Covidien · Apr 2014