Cleared Traditional

MEDICAL, DISPOSABLE BEDDING (K850067) - FDA 510(k) Clearance

Class I General Hospital device.

K850067 · East Texas Lighthouse For the Blind · General Hospital
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Apr 1985
Decision
101d
Days
Class 1
Risk

K850067 is an FDA 510(k) clearance for the MEDICAL, DISPOSABLE BEDDING. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by East Texas Lighthouse For the Blind (Tyler, US). The FDA issued a Cleared decision on April 19, 1985 after a review of 101 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 East Texas Lighthouse For the Blind devices

Submission Details

510(k) Number K850067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date April 19, 1985
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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.

Regulatory Peers - KME Bedding, Disposable, Medical

Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K850067.
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
TOWELS, SHEETS, PILLOWCASES
K781227 · Abco Dealers, Inc. · Oct 1978
PILLOWS- SINGLE PATIENT USE
K781354 · Abco Dealers, Inc. · Oct 1978
PLASTIC DISPOSABLE BIB
K761108 · Fred Sammons, Inc. · Dec 1976
TERRYCLOTH BIBS
K761109 · Fred Sammons, Inc. · Dec 1976