Cleared Traditional

MOLINEA UNDERPADS (K843402) - FDA 510(k) Clearance

Class I General Hospital device.

K843402 · Paul Hartmann Corp. · General Hospital
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Sep 1984
Decision
8d
Days
Class 1
Risk

K843402 is an FDA 510(k) clearance for the MOLINEA UNDERPADS. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Paul Hartmann Corp. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 8 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Paul Hartmann Corp. devices

Submission Details

510(k) Number K843402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1984
Decision Date September 07, 1984
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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.