Cleared Traditional

RECOVER INFANT HEEL WARMER (5100) (K964523) - FDA 510(k) Clearance

Class I Physical Medicine device.

K964523 · Florida Medical Industries, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
90d
Days
Class 1
Risk

K964523 is an FDA 510(k) clearance for the RECOVER INFANT HEEL WARMER (5100). Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Florida Medical Industries, Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on February 10, 1997 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.

View all Florida Medical Industries, Inc. devices

Submission Details

510(k) Number K964523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date February 10, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.