Cleared Traditional

K942311 - DYNASTY U1-33 AGM

K942311 is an FDA 510(k) clearance for DYNASTY U1-33 AGM, 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.

K942311 · Foley & Lardner · Physical Medicine device
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Nov 1994
Decision
178d
Days
Class 1
Risk

K942311 is an FDA 510(k) clearance for the DYNASTY U1-33 AGM. 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.

View all Foley & Lardner devices

FDA 510(k) Submission Details - K942311

510(k) Number K942311 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.

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 12
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K942311.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
WHEELCHAIR ACCESSORIES
K840629 · Poirier S.A. · Feb 1984