Cleared Traditional

K053254 - INFANT HEEL WARMER BY INTCO

K053254 is an FDA 510(k) clearance for INFANT HEEL WARMER BY INTCO, manufactured by Shanghai Intco Medical Supply Co., Ltd.. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K053254 · Shanghai Intco Medical Supply Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
302d
Days
Class 1
Risk

K053254 is an FDA 510(k) clearance for the INFANT HEEL WARMER BY INTCO. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Shanghai Intco Medical Supply Co., Ltd. (Chino, US). The FDA issued a Cleared decision on September 19, 2006 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K053254

510(k) Number K053254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date September 19, 2006
Days to Decision 302 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
186d slower than avg
Panel avg: 116d · This submission: 302d
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)

All 10
Devices cleared under the same product code (MPO) and FDA review panel - the closest regulatory comparables to K053254.
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · CooperSurgical, Inc. · Mar 2016
Rapid Aid Instant Disposable Infant Heel Warmer
K150627 · Rapid Aid Corp. · May 2015
DENOVO TEDDY GEL INFANT HEEL WARMER
K103549 · Denovo Products, LLC · Apr 2011
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
K040856 · Rapid Aid , Ltd. · May 2004
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004
MEDI-HEAT INFANT HEEL WARMER
K032989 · Mediheat, Inc. · Oct 2003
K053254 · INFANT HEEL WARMER BY INTCO
Download PDF FDA Summary Shanghai Intco Medica…