Cleared Traditional

K891986 - MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE

K891986 is an FDA 510(k) clearance for MULTIPLE-VARIOUS TYPES OF ABSORBENT INC..., manufactured by Mark One Healthcare Products. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 276-day FDA review.

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.

FDA 510(k) Submission Details - K891986

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
147d slower than avg
Panel avg: 129d · This submission: 276d
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

All 38
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K891986.
CHEM-SLEEVE
K901629 · Haz-Med, Inc. · Apr 1990
FLUID SOAKERSHIELD
K900643 · Infection Control Products, Inc. · Apr 1990
MATTRESS COVER FOR MEDICAL PURPOSES
K896043 · Keystone Veterinary Supplies, Inc. · Jan 1990
DEVON DISPOSABLE HEAD POSITIONER COVER
K894170 · Devon Industries, Inc. · Sep 1989
DEPEND UNDERPAD
K870522 · Kimberly-Clark Corp. · Mar 1987
KIMLON DISPOSABLE BLANKET
K863179 · Kimberly-Clark Corp. · Aug 1986
K891986 · MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
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