Cleared Traditional

K844176 - PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS

K844176 is an FDA 510(k) clearance for PREMIE COMFORT PAD PATIENT & INFANT SUP..., manufactured by Premie Comfort Products. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K844176

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.

FRP Device Classification - Class 1, General Controls

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.