Cleared Traditional

K954716 - DEROYAL INDUSTRIES INFANT HEEL WARMER

K954716 is an FDA 510(k) clearance for DEROYAL INDUSTRIES INFANT HEEL WARMER, manufactured by Debusk Knitting Mills, Div. Deroyal Industries. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K954716 · Debusk Knitting Mills, Div. Deroyal Industries · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
90d
Days
Class 1
Risk

K954716 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES INFANT HEEL WARMER. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Debusk Knitting Mills, Div. Deroyal Industries (Powell, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K954716

510(k) Number K954716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date January 11, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

MPO Device Classification - Class 1, General Controls

Product Code MPO Infant Heel Warmer (chemical Heat Pack)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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.

K954716 · DEROYAL INDUSTRIES INFANT HEEL WARMER
Download PDF FDA Summary Debusk Knitting Mills…