Cleared Traditional

K132229 - OMNI PATENT MONITORS

K132229 is an FDA 510(k) clearance for OMNI PATENT MONITORS, 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 218-day FDA review.

K132229 · Infinium Medical · Cardiovascular device
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Feb 2014
Decision
218d
Days
Class 2
Risk

K132229 is an FDA 510(k) clearance for the OMNI PATENT MONITORS. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Infinium Medical (Apollo Beach, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 218 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.

View all Infinium Medical devices

FDA 510(k) Submission Details - K132229

510(k) Number K132229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2013
Decision Date February 21, 2014
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 175
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K132229.
740 SELECT
K140430 · Cas Medical Systems, Inc. · Jun 2014
HANDHELD MONITOR
K131762 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K140339 · Covidien · Apr 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · Guangdong Biolight Meditech Co., Ltd. · Feb 2014
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · Welch Allyn, Inc. · Jan 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · Covidien · Dec 2013