Cleared Traditional

K830285 - REGNELL HYDRAULIC FEMORAL PROTHESIS

K830285 is an FDA 510(k) clearance for REGNELL HYDRAULIC FEMORAL PROTHESIS, manufactured by Besco Financial Service. The device is a Class 2 Physical Medicine device with product code KFX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830285 · Besco Financial Service · Physical Medicine device
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Mar 1983
Decision
41d
Days
Class 2
Risk

K830285 is an FDA 510(k) clearance for the REGNELL HYDRAULIC FEMORAL PROTHESIS. Classified as Assembly, Thigh/knee/shank/ankle/foot, External (product code KFX), Class II - Special Controls.

Submitted by Besco Financial Service (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3500 - 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 - K830285

510(k) Number K830285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1983
Decision Date March 09, 1983
Days to Decision 41 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
75d faster than avg
Panel avg: 116d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFX Device Classification - Class 2, Special Controls

Product Code KFX Assembly, Thigh/knee/shank/ankle/foot, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3500
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.

K830285 · REGNELL HYDRAULIC FEMORAL PROTHESIS
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