Cleared Traditional

K872911 - CYBEX 340

K872911 is an FDA 510(k) clearance for CYBEX 340, manufactured by Cybex. The device is a Class 2 Physical Medicine device with product code IKK cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K872911 · Cybex · Physical Medicine device
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Sep 1987
Decision
62d
Days
Class 2
Risk

K872911 is an FDA 510(k) clearance for the CYBEX 340. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on September 24, 1987 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1925 - 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.

View all Cybex devices

FDA 510(k) Submission Details - K872911

510(k) Number K872911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date September 24, 1987
Days to Decision 62 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKK Device Classification - Class 2, Special Controls

Product Code IKK System, Isokinetic Testing And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IKK System, Isokinetic Testing And Evaluation

All 9
Devices cleared under the same product code (IKK) and FDA review panel - the closest regulatory comparables to K872911.
SINGLE CHAIR INTEGRAL BACK ATTACHMENT
K922092 · Biodan Medical Systems, Ltd. · May 1992
KIN-COM ASYMMETRICAL BACK SYSTEM
K911805 · Chattanooga Group, Inc. · Jul 1991
ISOKINETIC SYSTEM, TESTING AND EVALUATION
K875235 · Orthopedic Systems, Inc. · Jan 1988
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
K861622 · Orthopedic Systems, Inc. · May 1986