Cleared Traditional

PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS (K844176) - FDA 510(k) Clearance

Class I General Hospital device.

K844176 · Premie Comfort Products · General Hospital
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Jan 1985
Decision
90d
Days
Class 1
Risk

K844176 is an FDA 510(k) clearance for the PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Premie Comfort Products (Dallas, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5680 - 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.

View all Premie Comfort Products devices

Submission Details

510(k) Number K844176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1984
Decision Date January 23, 1985
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRP Holder, Infant Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
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.