Cleared Traditional

K953864 - SILCLEAR TUBING (MODIFICATION)

K953864 is an FDA 510(k) clearance for SILCLEAR TUBING (MODIFICATION), manufactured by Degania Silicone , Ltd.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K953864

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FPK Tubing, Fluid Delivery

All 30
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K953864.
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RECONSTITUTION ACCESSOREIS
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SILCLEAR TUBING
K943992 · Degania Silicone , Ltd. · Mar 1995