Cleared Traditional

K880018 - LIDO(TM) WORKSET

K880018 is the FDA 510(k) clearance for LIDO(TM) WORKSET by Loredan Biomedical, Inc.. It is a Class 2 Physical Medicine device (product code IKK) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K880018 · Loredan Biomedical, Inc. · Physical Medicine device
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Feb 1988
Decision
52d
Days
Class 2
Risk

K880018 is an FDA 510(k) clearance for the LIDO(TM) WORKSET. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Loredan Biomedical, Inc. (Davis, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 52 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 Loredan Biomedical, Inc. devices

Submission Details

510(k) Number K880018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date February 26, 1988
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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