Cleared Traditional

K950192 - SKYTRON SKYBOOM SERIES

K950192 is an FDA 510(k) clearance for SKYTRON SKYBOOM SERIES, manufactured by Skytron, Div. the Kmw Group, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K950192 · Skytron, Div. the Kmw Group, Inc. · General & Plastic Surgery device
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Apr 1995
Decision
75d
Days
Class 1
Risk

K950192 is an FDA 510(k) clearance for the SKYTRON SKYBOOM SERIES. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 75 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

FDA 510(k) Submission Details - K950192

510(k) Number K950192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date April 03, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

FQO Device Classification - Class 1, General Controls

Product Code FQO Table, Operating-room, 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.

Regulatory Peers - FQO Table, Operating-room, Ac-powered

All 17
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