Cleared Traditional

K030479 - JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET

K030479 is an FDA 510(k) clearance for JMS SYSLOC A.V. FISTULA NEEDLE SET, manufactured by Jms North America Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K030479 · Jms North America Corp. · General Hospital
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Aug 2003
Decision
186d
Days
Class 2
Risk

K030479 is an FDA 510(k) clearance for the JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Jms North America Corp. (Hayward, US). The FDA issued a Cleared decision on August 18, 2003 after a review of 186 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 Jms North America Corp. devices

FDA 510(k) Submission Details - K030479

510(k) Number K030479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2003
Decision Date August 18, 2003
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 417
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