Cleared Traditional

DYNASTY GC 12400 (GELL/CELL) (K942308) - FDA 510(k) Clearance

Class I Physical Medicine device.

K942308 · Foley & Lardner · Physical Medicine device
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Nov 1994
Decision
178d
Days
Class 1
Risk

K942308 is an FDA 510(k) clearance for the DYNASTY GC 12400 (GELL/CELL). Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Foley & Lardner (Washington, US). The FDA issued a Cleared decision on November 7, 1994 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K942308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1994
Decision Date November 07, 1994
Days to Decision 178 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 63
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K942308.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
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ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · Fred Sammons, Inc. · Jan 1982
DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · Fred Sammons, Inc. · Sep 1981