Cleared Special

K103737 - OMNI II PATIENT MONITOR

K103737 is an FDA 510(k) clearance for OMNI II PATIENT MONITOR, manufactured by Infinium Medical. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 162-day FDA review.

K103737 · Infinium Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
162d
Days
Class 2
Risk

K103737 is an FDA 510(k) clearance for the OMNI II 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 June 2, 2011 after a review of 162 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103737

510(k) Number K103737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2010
Decision Date June 02, 2011
Days to Decision 162 days
Submission Type Special
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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Modification to existing cleared device.

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 K103737.
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