Cleared Traditional

K972535 - MAGLIFE C

K972535 is an FDA 510(k) clearance for MAGLIFE C, manufactured by Odam. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K972535 · Odam · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1998
Decision
189d
Days
Class 2
Risk

K972535 is an FDA 510(k) clearance for the MAGLIFE C. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Odam (North Attleboro, US). The FDA issued a Cleared decision on January 13, 1998 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Odam devices

FDA 510(k) Submission Details - K972535

510(k) Number K972535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1997
Decision Date January 13, 1998
Days to Decision 189 days
Submission Type Traditional
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
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 404
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K972535.
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
K973474 · Witt Biomedical Corporation · Mar 1998
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM
K971840 · Invivo Research, Inc. · Mar 1998
VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300
K970445 · Pace Tech Medical Monitors, Inc. · Jan 1998
DINAMAP COMPACT MONITOR
K970182 · Johnson & Johnson Medical, Inc. · Aug 1997
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
K922668 · Colin Medical Instruments Corp. · Jan 1997
NPB-4000
K962424 · Analogic Corp. · Dec 1996