Cleared Traditional

K840492 - SUN-LITE BLUE SLIT (FDA 510(k) Clearance)

Class I Orthopedic device.

K840492 · Suncoast Medical Manufacturers, Inc. · Orthopedic device
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May 1984
Decision
93d
Days
Class 1
Risk

K840492 is an FDA 510(k) clearance for the SUN-LITE BLUE SLIT. Classified as File (product code HTP), Class I - General Controls.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Suncoast Medical Manufacturers, Inc. devices

Submission Details

510(k) Number K840492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date May 09, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTP File
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.