Cleared Traditional

K982652 - ALLEGIANCE PORTA-WARM MATTRESS

K982652 is an FDA 510(k) clearance for ALLEGIANCE PORTA-WARM MATTRESS, manufactured by Allegiance Healthcare Corp.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K982652 · Allegiance Healthcare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
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Jan 1999
Decision
175d
Days
Class 1
Risk

K982652 is an FDA 510(k) clearance for the ALLEGIANCE PORTA-WARM MATTRESS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on January 21, 1999 after a review of 175 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.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K982652

510(k) Number K982652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1998
Decision Date January 21, 1999
Days to Decision 175 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
60d slower than avg
Panel avg: 115d · This submission: 175d
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 Peers - IMD Pack, Hot Or Cold, Disposable

All 20
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K982652.
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