Cleared Traditional

MAGLIFE (K950264) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950264 · Odam · Cardiovascular device
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Sep 1996
Decision
613d
Days
Class 2
Risk

K950264 is an FDA 510(k) clearance for the MAGLIFE. 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 September 27, 1996 after a review of 613 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Odam devices

Submission Details

510(k) Number K950264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1995
Decision Date September 27, 1996
Days to Decision 613 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
488d slower than avg
Panel avg: 125d · This submission: 613d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 133
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K950264.
LIFE SCOPE EC, MODEL BSM-1102
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K990563 · Siemens Medical Solutions USA, Inc. · Mar 1999
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994
HEWLETT-PACKARD MODEL 78730 CAREVUE 5000
K922210 · Hewlett-Packard Co. · Apr 1993
PORTABLE PATIENT MONITOR
K922974 · Hewlett-Packard Co. · Dec 1992