Cleared Special

K150627 - Rapid Aid Instant Disposable Infant Heel Warmer

K150627 is an FDA 510(k) clearance for Rapid Aid Instant Disposable Infant Hee..., manufactured by Rapid Aid Corp.. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Special 510(k) pathway after a 77-day FDA review.

K150627 · Rapid Aid Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
77d
Days
Class 1
Risk

K150627 is an FDA 510(k) clearance for the Rapid Aid Instant Disposable Infant Heel Warmer. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Rapid Aid Corp. (Mississauga, CA). The FDA issued a Cleared decision on May 27, 2015 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K150627

510(k) Number K150627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2015
Decision Date May 27, 2015
Days to Decision 77 days
Submission Type Special
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
39d faster than avg
Panel avg: 116d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Mandell Horwitz Consultants, LLC
Diane Horwitz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150627.
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
DENOVO TEDDY GEL INFANT HEEL WARMER
K103549 · Denovo Products, LLC · Apr 2011
INFANT HEEL WARMER BY INTCO
K053254 · Shanghai Intco Medical Supply Co., Ltd. · Sep 2006
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
K040856 · Rapid Aid , Ltd. · May 2004
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004
K150627 · Rapid Aid Instant Disposable Infant Heel Warmer
Download PDF FDA Summary Rapid Aid Corp.