Cleared Traditional

K900643 - FLUID SOAKERSHIELD

K900643 is an FDA 510(k) clearance for FLUID SOAKERSHIELD, manufactured by Infection Control Products, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K900643 · Infection Control Products, Inc. · General Hospital
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Apr 1990
Decision
75d
Days
Class 1
Risk

K900643 is an FDA 510(k) clearance for the FLUID SOAKERSHIELD. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Infection Control Products, Inc. (Gardendale, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - the FDA general hospital 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 Infection Control Products, Inc. devices

FDA 510(k) Submission Details - K900643

510(k) Number K900643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date April 25, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

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