Cleared Traditional

K101052 - OMNI III PATIENT MONITOR

K101052 is an FDA 510(k) clearance for OMNI III PATIENT MONITOR, manufactured by Infinium Medical. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K101052 · Infinium Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
118d
Days
Class 2
Risk

K101052 is an FDA 510(k) clearance for the OMNI III PATIENT MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Infinium Medical (Appollo Beach, US). The FDA issued a Cleared decision on August 11, 2010 after a review of 118 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.

FDA 510(k) Submission Details - K101052

510(k) Number K101052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2010
Decision Date August 11, 2010
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K101052.
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
K101571 · Witt Biomedical Corp · Oct 2010
VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
K102135 · Nuvon, Inc. · Oct 2010
CARESCAPE MODEL V100 VITAL SIGNS MONITOR
K102426 · Ge Medical Systems Information Technologies · Oct 2010
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
K100133 · Airstrip Technologies, LP · Jul 2010
WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0
K101674 · Athena Gtx · Jul 2010
MD2000B VITAL SIGN MONITOR, MODEL MD2000B
K100740 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2010