Cleared Special

K150627 - Rapid Aid Instant Disposable Infant Heel Warmer (FDA 510(k) Clearance)

Class I Physical Medicine device.

K150627 · Rapid Aid Corp. · Physical Medicine device
Download Printable Device Report (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.

View all Rapid Aid Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

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.