Cleared Traditional

K840492 - SUN-LITE BLUE SLIT

K840492 is an FDA 510(k) clearance for SUN-LITE BLUE SLIT, manufactured by Suncoast Medical Manufacturers, Inc.. The device is a Class 1 Orthopedic device with product code HTP cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K840492

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

HTP Device Classification - Class 1, General Controls

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.