Cleared Traditional

SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (K900472) - FDA 510(k) Clearance

Class I Neurology device.

K900472 · Skytron, Div. the Kmw Group, Inc. · Neurology device
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Sep 1990
Decision
216d
Days
Class 1
Risk

K900472 is an FDA 510(k) clearance for the SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI. Classified as Chair, Neurosurgical (product code HBN), Class I - General Controls.

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 216 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4125 - the FDA neurology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Skytron, Div. the Kmw Group, Inc. devices

Submission Details

510(k) Number K900472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1990
Decision Date September 04, 1990
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 148d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HBN Chair, Neurosurgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4125
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.