Cleared Traditional

K021130 - SPECATH CENTRAL VENOUS CATHETER KITS

K021130 is an FDA 510(k) clearance for SPECATH CENTRAL VENOUS CATHETER KITS, manufactured by Special Medical Co. , Ltd.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K021130 · Special Medical Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
273d
Days
Class 2
Risk

K021130 is an FDA 510(k) clearance for the SPECATH CENTRAL VENOUS CATHETER KITS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Special Medical Co. , Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 7, 2003 after a review of 273 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Special Medical Co. , Ltd. devices

FDA 510(k) Submission Details - K021130

510(k) Number K021130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date January 07, 2003
Days to Decision 273 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
144d slower than avg
Panel avg: 129d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 391
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K021130.
SPECTRUM SILICONE CATHETER
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K030571 · Ethicon Endo-Surgery, Inc. · Mar 2003
NIPRO BIO-FLEX CATHETER
K022756 · Nipro Medical Corp. · Oct 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
K022099 · Hdc Corp. · Sep 2002
INTROCAN SAFETY IV CATHETER
K020785 · B.Braun Medical, Inc. · Aug 2002