Cleared Traditional

K944240 - SOFT SOCK

K944240 is an FDA 510(k) clearance for SOFT SOCK, manufactured by Silipos, Inc.. The device is a Class 1 General Hospital device with product code FQL cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K944240 · Silipos, Inc. · General Hospital
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Dec 1994
Decision
117d
Days
Class 1
Risk

K944240 is an FDA 510(k) clearance for the SOFT SOCK. Classified as Stocking, Medical Support (for General Medical Purposes) (product code FQL), Class I - General Controls.

Submitted by Silipos, Inc. (Niagra Falls, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Silipos, Inc. devices

FDA 510(k) Submission Details - K944240

510(k) Number K944240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date December 27, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

FQL Device Classification - Class 1, General Controls

Product Code FQL Stocking, Medical Support (for General Medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5780
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.