Cleared Traditional

K831728 - MEDICALEX (FDA 510(k) Clearance)

Class I General Hospital device.

K831728 · Medicalex · General Hospital
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Jan 1984
Decision
223d
Days
Class 1
Risk

K831728 is an FDA 510(k) clearance for the MEDICALEX. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Medicalex (Mchenry, US). The FDA issued a Cleared decision on January 9, 1984 after a review of 223 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K831728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date January 09, 1984
Days to Decision 223 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 128d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.