Cleared Traditional

K955433 - DURALASTIC SILICONE TUBING

K955433 is an FDA 510(k) clearance for DURALASTIC SILICONE TUBING, manufactured by Allied Biomedical Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGZ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K955433 · Allied Biomedical Corp. · General & Plastic Surgery device
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Jan 1996
Decision
59d
Days
Class 1
Risk

K955433 is an FDA 510(k) clearance for the DURALASTIC SILICONE TUBING. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Allied Biomedical Corp. (Paso Robles, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allied Biomedical Corp. devices

FDA 510(k) Submission Details - K955433

510(k) Number K955433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date January 26, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

KGZ Device Classification - Class 1, General Controls

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.

Regulatory Peers - KGZ Accessories, Catheter

All 19
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K955433.
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
K974295 · Byron Medical · Feb 1998
WOUND DRAINAGE HOLDER
K973183 · R & D Medical Products, Inc. · Jan 1998
PALESTRANT IRRIGATION AND DRAINAGE SET
K896087 · North American Instrument Corp. · Nov 1989
OPTICAL CATHETER(TM) INTRODUCER SETS
K895041 · Medical Dynamics, Inc. · Oct 1989
DESERET PRN ADAPTER
K893406 · Deseret Medical, Inc. · Jun 1989
CONCEPT SWITCHING STICK
K873009 · Concept, Inc. · Aug 1987