Cleared Traditional

K032292 - BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX

K032292 is an FDA 510(k) clearance for BIOTEQUE A.V. FISTULA NEEDLE SET WITH S..., manufactured by Bioteque Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K032292 · Bioteque Corp. · General Hospital
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Mar 2004
Decision
242d
Days
Class 2
Risk

K032292 is an FDA 510(k) clearance for the BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bioteque Corp. (Flagstaff, US). The FDA issued a Cleared decision on March 22, 2004 after a review of 242 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 Bioteque Corp. devices

FDA 510(k) Submission Details - K032292

510(k) Number K032292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2003
Decision Date March 22, 2004
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 384
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