Cleared Traditional

SKYTRON MODEL 1100 AND MODEL 142 (K900290) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K900290 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
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Feb 1990
Decision
29d
Days
Class 1
Risk

K900290 is an FDA 510(k) clearance for the SKYTRON MODEL 1100 AND MODEL 142. Classified as Table, Surgical With Orthopedic Accessories, Ac-powered (product code JEA), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 20, 1990 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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 Skytron, Div. the Kmw Group, Inc. devices

Submission Details

510(k) Number K900290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1990
Decision Date February 20, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JEA Table, Surgical With Orthopedic Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.