Cleared Traditional

Vitals360 Multi-Vitals Mobile Monitor (K210086) - FDA 510(k) Clearance

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

K210086 · Vocare, Inc. · Cardiovascular device
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May 2021
Decision
127d
Days
Class 2
Risk

K210086 is an FDA 510(k) clearance for the Vitals360 Multi-Vitals Mobile Monitor. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Vocare, Inc. (Zionsville, US). The FDA issued a Cleared decision on May 20, 2021 after a review of 127 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 Vocare, Inc. devices

Submission Details

510(k) Number K210086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2021
Decision Date May 20, 2021
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
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 114
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K210086.
Capsule Vitals Plus Patient Monitoring System
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K212227 · Invivo Corporation · Sep 2021
ZOLL Propaq M
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740 SafeSAT
K200160 · Zoe Medical, Inc. · Feb 2021
MouthLab Vital Signs Monitoring System
K201635 · Multisensor Diagnostics (Dba Aidar Health) · Feb 2021