Cleared Special

K090785 - MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214

K090785 is an FDA 510(k) clearance for MRI COMPATIBLE PATIENT MONITORING SYSTEM, manufactured by Invivo Corp.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 267-day FDA review.

K090785 · Invivo Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
267d
Days
Class 2
Risk

K090785 is an FDA 510(k) clearance for the MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Invivo Corp. (Orlando, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 267 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 - K090785

510(k) Number K090785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date December 15, 2009
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
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)

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K090785 · MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
Download PDF FDA Summary Invivo Corp.