Cleared Traditional

K964523 - RECOVER INFANT HEEL WARMER (5100)

K964523 is an FDA 510(k) clearance for RECOVER INFANT HEEL WARMER (5100), manufactured by Florida Medical Industries, Inc.. 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.

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

FDA 510(k) Submission Details - K964523

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · 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.

Regulatory Peers - MPO Infant Heel Warmer (chemical Heat Pack)

Devices cleared under the same product code (MPO) and FDA review panel - the closest regulatory comparables to K964523.
Infant Heel WarmerTM
K221154 · International Biomedical · Oct 2022
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · CooperSurgical, Inc. · Mar 2016
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004
BAXTER SODIUM ACETATE INFANT HEEL WARMER
K961154 · Baxter Healthcare Corp · Jun 1996