Cleared Traditional

K853880 - ATTENDS DISPOS. UNDERPAD

K853880 is an FDA 510(k) clearance for ATTENDS DISPOS. UNDERPAD, manufactured by Procter & Gamble Mfg. Co.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853880 · Procter & Gamble Mfg. Co. · General Hospital
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Oct 1985
Decision
28d
Days
Class 1
Risk

K853880 is an FDA 510(k) clearance for the ATTENDS DISPOS. UNDERPAD. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 28 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.

FDA 510(k) Submission Details - K853880

510(k) Number K853880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1985
Decision Date October 16, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
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 64
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K853880.
SINGLE-USE PATIENT UNDERPAD
K862348 · Procter & Gamble Mfg. Co. · Jul 1986
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ALPHA CHUCK
K853970 · Rocky Mountain Medical Corp. · Nov 1985
MEDICAL, DISPOSABLE BEDDING
K850067 · East Texas Lighthouse For the Blind · Apr 1985
PAD, PRE-OPERATIVE PREPARATION
K850811 · East Texas Lighthouse For the Blind · Mar 1985
SHAVE PREP TRAY
K850544 · Packaging Technologies, Inc. · Mar 1985
K853880 · ATTENDS DISPOS. UNDERPAD
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