Cleared Traditional

K122036 - VISI MOBILE MONITORING SYSTEM

K122036 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 35-day FDA review.

K122036 · Sotera Wireless, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
35d
Days
Class 2
Risk

K122036 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 August 15, 2012 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sotera Wireless, Inc. devices

FDA 510(k) Submission Details - K122036

510(k) Number K122036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2012
Decision Date August 15, 2012
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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. 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 160
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