Cleared Traditional

COUGH PILLOW (K893809) - FDA 510(k) Clearance

Class I General Hospital device.

K893809 · Custom Hospitals Products · General Hospital
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Aug 1989
Decision
98d
Days
Class 1
Risk

K893809 is an FDA 510(k) clearance for the COUGH PILLOW. Classified as Binder, Elastic (product code KMO), Class I - General Controls.

Submitted by Custom Hospitals Products (Portland, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Custom Hospitals Products devices

Submission Details

510(k) Number K893809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date August 28, 1989
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMO Binder, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5160
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.