Cleared Traditional

K942310 - DYNASTY GC 12550 (GELL/CELL)

K942310 is an FDA 510(k) clearance for DYNASTY GC 12550 (GELL/CELL), manufactured by Foley & Lardner. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K942310 · Foley & Lardner · Physical Medicine device
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Nov 1994
Decision
178d
Days
Class 1
Risk

K942310 is an FDA 510(k) clearance for the DYNASTY GC 12550 (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.

FDA 510(k) Submission Details - K942310

510(k) Number K942310 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 116d · This submission: 178d
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 49
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K942310.
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DYNASTY GC 12400 (GELL/CELL)
K942308 · Foley & Lardner · Nov 1994
DYNASTY U1-31 (GELL/CELL)
K942309 · Foley & Lardner · Nov 1994
DYNASTY U1-33 AGM
K942311 · Foley & Lardner · Nov 1994
ALDEN WHEELCHAIR CUSHION
K942260 · Ward and Assoc. · May 1994
ALDEN LINEAGE WHEELCHAIR CUSHION
K942312 · Lewis W. Ward · May 1994
K942310 · DYNASTY GC 12550 (GELL/CELL)
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