Cleared Special

K124061 - MRI PATIENT MONITORING SYSTEM (MODEL 865214)

K124061 is an FDA 510(k) clearance for MRI PATIENT MONITORING SYSTEM (MODEL 86..., manufactured by Invivo Corporation. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 53-day FDA review.

K124061 · Invivo Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
53d
Days
Class 2
Risk

K124061 is an FDA 510(k) clearance for the MRI 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 Corporation (Orlando, US). The FDA issued a Cleared decision on February 22, 2013 after a review of 53 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Invivo Corporation devices

FDA 510(k) Submission Details - K124061

510(k) Number K124061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2012
Decision Date February 22, 2013
Days to Decision 53 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K124061.
PATIENT MONITOR
K130056 · Ld Technology, LLC · Apr 2013
NUVON VITALS CHARTING SYSTEM
K130234 · Nuvon, Inc. · Mar 2013
VITAL SYNC SYSTEM
K123002 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Feb 2013
COMEN MULTI-PARAMETER PATIENT MONITOR
K112877 · Goldway Us, Inc. · Nov 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K122133 · Airstrip Technologies, LP · Oct 2012
VISI MOBILE MONITORING SYSTEM
K122036 · Sotera Wireless, Inc. · Aug 2012