Cleared Traditional

K112478 - VISI MOBILE MONITORING SYSTEM

K112478 is an FDA 510(k) clearance for VISI MOBILE MONITORING SYSTEM, manufactured by Sotera Wireless, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K112478 · Sotera Wireless, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
206d
Days
Class 2
Risk

K112478 is an FDA 510(k) clearance for the VISI MOBILE MONITORING SYSTEM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Sotera Wireless, Inc. (San Diego, US). The FDA issued a Cleared decision on March 22, 2012 after a review of 206 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K112478

510(k) Number K112478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date March 22, 2012
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

MWI Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00881829 Unknown Observational

Hypoxia Blood Validation in Multiple Pulse Oximeters

Accuracy Validation in Multiple SpO2 Systems

500
Patients (est.)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator David Ransom, MD
Sponsor Clinimark, LLC
Started 2016-08-09 → Primary completion 2021-12-21
Primary outcome
Completion of study by all subjects
View full study on ClinicalTrials.gov

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K112478.
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MINI-MEDIC
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