Cleared Traditional

K130709 - VISI MOBILE MONITORING SYSTEM

K130709 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.

K130709 · Sotera Wireless, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
206d
Days
Class 2
Risk

K130709 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 October 7, 2013 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 - K130709

510(k) Number K130709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2013
Decision Date October 07, 2013
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 K130709.
BM3/BM3 PLUS
K132033 · Noblitt & Rueland · Dec 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · Covidien · Dec 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
PATIENT MONITOR
K123711 · Shenzhen Creative Industry Co., Ltd. · Oct 2013
MRI PATIENT MONITORING SYSTEM
K132359 · Invivo Corporation · Aug 2013
NIGHTINGALE MONITORING SYSTEM
K130740 · Zoe Medical, Inc. · Jul 2013