Cleared Traditional

K801936 - PAD, EXAMINING TABLE

K801936 is an FDA 510(k) clearance for PAD, manufactured by Volunteer Blind Industries, Inc.. The device is a Class 1 General Hospital device with product code KMN cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K801936 · Volunteer Blind Industries, Inc. · General Hospital
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Aug 1980
Decision
15d
Days
Class 1
Risk

K801936 is an FDA 510(k) clearance for the PAD, EXAMINING TABLE. Classified as Chair And Table, Medical (product code KMN), Class I - General Controls.

Submitted by Volunteer Blind Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6140 - 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.

View all Volunteer Blind Industries, Inc. devices

FDA 510(k) Submission Details - K801936

510(k) Number K801936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1980
Decision Date August 27, 1980
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

KMN Device Classification - Class 1, General Controls

Product Code KMN Chair And Table, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6140
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.