Cleared Traditional

K163295 - Infant Transport Mattress Warmer with Disc

K163295 is an FDA 510(k) clearance for Infant Transport Mattress Warmer with Disc, manufactured by Rapid Aid Corp.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K163295 · Rapid Aid Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
244d
Days
Class 1
Risk

K163295 is an FDA 510(k) clearance for the Infant Transport Mattress Warmer with Disc. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Rapid Aid Corp. (Mississauga, CA). The FDA issued a Cleared decision on July 24, 2017 after a review of 244 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K163295

510(k) Number K163295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date July 24, 2017
Days to Decision 244 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
128d slower than avg
Panel avg: 116d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
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
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 - IMD Pack, Hot Or Cold, Disposable

All 54
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K163295.
InfaTherm Disposable Infant Warming Mattress
K221653 · International Biomedical · Oct 2022
NEO NEST
K112547 · Denovo Proucts, LLC · Mar 2012
EYEFEEL OPHTHALMIC WARMER
K082087 · Bio-Lipid, Inc. · Sep 2008
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K071710 · Johnson & Johnson Consumer Products, Inc. · Aug 2007
EYEFEEL OPHTHALMIC WARMER
K021843 · Bio-Lipid, Inc. · Sep 2002
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · Allegiance Healthcare Corp. · Jan 1999
K163295 · Infant Transport Mattress Warmer with Disc
Download PDF FDA Summary Rapid Aid Corp.