Cleared Traditional

SMARTSTEP SYSTEM (K023161) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023161 · Andante Medical Device, Ltd. · Physical Medicine device
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Dec 2002
Decision
78d
Days
Class 2
Risk

K023161 is an FDA 510(k) clearance for the SMARTSTEP SYSTEM. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Andante Medical Device, Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on December 10, 2002 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - 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 Andante Medical Device, Ltd. devices

Submission Details

510(k) Number K023161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date December 10, 2002
Days to Decision 78 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRN Device, Warning, Overload, External Limb, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5575
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.