Cleared Traditional

K953864 - SILCLEAR TUBING (MODIFICATION) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953864 · Degania Silicone , Ltd. · General Hospital
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Nov 1995
Decision
91d
Days
Class 2
Risk

K953864 is an FDA 510(k) clearance for the SILCLEAR TUBING (MODIFICATION). Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on November 6, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Degania Silicone , Ltd. devices

Submission Details

510(k) Number K953864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date November 06, 1995
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.