Cleared Traditional

K083429 - I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT

K083429 is an FDA 510(k) clearance for I.V. CATHETER, manufactured by Weihai Jierui Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K083429 · Weihai Jierui Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
261d
Days
Class 2
Risk

K083429 is an FDA 510(k) clearance for the I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Weihai Jierui Medical Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 7, 2009 after a review of 261 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 Weihai Jierui Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K083429

510(k) Number K083429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date August 07, 2009
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
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 349
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