Cleared Traditional

K781227 - TOWELS, SHEETS, PILLOWCASES

K781227 is an FDA 510(k) clearance for TOWELS, manufactured by Abco Dealers, Inc.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K781227 · Abco Dealers, Inc. · General Hospital
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Oct 1978
Decision
91d
Days
Class 1
Risk

K781227 is an FDA 510(k) clearance for the TOWELS, SHEETS, PILLOWCASES. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Abco Dealers, Inc.. The FDA issued a Cleared decision on October 17, 1978 after a review of 91 days - within the typical 510(k) review window.

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.

View all Abco Dealers, Inc. devices

FDA 510(k) Submission Details - K781227

510(k) Number K781227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1978
Decision Date October 17, 1978
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 25
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K781227.
STERILIZATION PROCESS/BABY BLANKET
K792626 · Procter & Gamble Mfg. Co. · Jan 1980
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978
PILLOWS- SINGLE PATIENT USE
K781354 · Abco Dealers, Inc. · Oct 1978
SHEET KIT, STRETCHER, DISPOSABLE
K770486 · American Hospital Supply Corp. · Apr 1977
PLASTIC DISPOSABLE BIB
K761108 · Fred Sammons, Inc. · Dec 1976