Cleared Traditional

CARESTATION 126S VIDEOPHONE (K031863) - FDA 510(k) Clearance

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

K031863 · Motion Media Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
116d
Days
Class 2
Risk

K031863 is an FDA 510(k) clearance for the CARESTATION 126S VIDEOPHONE. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Motion Media Technology, Inc. (Wilmington, US). The FDA issued a Cleared decision on October 10, 2003 after a review of 116 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 Motion Media Technology, Inc. devices

Submission Details

510(k) Number K031863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date October 10, 2003
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
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 77
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K031863.
Masimo Rad-97 and Accessories
K170168 · Masimo Corporation · Sep 2017
Unity Network ID
K170199 · Ge Healthcare · May 2017
Unity Network ID
K142840 · Ge Healthcare · Jan 2015
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · Nihon Kohden America, Inc. · Sep 2003
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · Eastman Kodak Company · Feb 2000