Cleared Traditional

CP&S DISPOSABLE INSTANT COLD COMPRESS (K890553) - FDA 510(k) Clearance

Class I Physical Medicine device.

K890553 · Consolidated Products & Services, Inc. · Physical Medicine device
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Feb 1989
Decision
7d
Days
Class 1
Risk

K890553 is an FDA 510(k) clearance for the CP&S DISPOSABLE INSTANT COLD COMPRESS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Consolidated Products & Services, Inc. (North Quincy, US). The FDA issued a Cleared decision on February 13, 1989 after a review of 7 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Consolidated Products & Services, Inc. devices

Submission Details

510(k) Number K890553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date February 13, 1989
Days to Decision 7 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K890553.
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