Cleared Traditional

K823876 - BERKELEY FORK

K823876 is an FDA 510(k) clearance for BERKELEY FORK, manufactured by Berkeley Electric Wheelchair Co.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K823876 · Berkeley Electric Wheelchair Co. · Physical Medicine device
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Jan 1983
Decision
17d
Days
Class 1
Risk

K823876 is an FDA 510(k) clearance for the BERKELEY FORK. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Berkeley Electric Wheelchair Co. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - the FDA physical medicine 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 - K823876

510(k) Number K823876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date January 14, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 116d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 62
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K823876.
CHAIN SILENCER
K823873 · Berkeley Electric Wheelchair Co. · Jan 1983
BERKELEY BRAKE
K823874 · Berkeley Electric Wheelchair Co. · Jan 1983
CHAIN KIT
K823875 · Berkeley Electric Wheelchair Co. · Jan 1983
BERKELEY HARNESS
K823877 · Berkeley Electric Wheelchair Co. · Jan 1983
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM
K821488 · Electro-Catheter Corp. · May 1982
PALM BEACH SEATING SYSTEM
K820761 · Pb Sales C/O Geller & Bozeman · Apr 1982
K823876 · BERKELEY FORK
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