Cleared Traditional

K891986 - MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (FDA 510(k) Clearance)

Class I General Hospital device.

K891986 · Mark One Healthcare Products · General Hospital
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Dec 1989
Decision
276d
Days
Class 1
Risk

K891986 is an FDA 510(k) clearance for the MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Mark One Healthcare Products (Runnemede, US). The FDA issued a Cleared decision on December 29, 1989 after a review of 276 days - an extended review 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: 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.

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Submission Details

510(k) Number K891986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date December 29, 1989
Days to Decision 276 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
148d slower than avg
Panel avg: 128d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.