Cleared Traditional

K850067 - MEDICAL, DISPOSABLE BEDDING

K850067 is an FDA 510(k) clearance for MEDICAL, manufactured by East Texas Lighthouse For the Blind. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K850067

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.

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 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K850067.
SINGLE-USE PATIENT UNDERPAD
K862348 · Procter & Gamble Mfg. Co. · Jul 1986
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
SHAVE PREP KITS
K842989 · Biological & Environmental Control Laboratories · Dec 1984
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
K844196 · Biological & Environmental Control Laboratories · Dec 1984
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984