Cleared Traditional

K032292 - BIOTEQUE A.V. FISTULA NEEDLE SET WITH S...

K032292 is the FDA 510(k) clearance for BIOTEQUE A.V. FISTULA NEEDLE SET WITH S... by Bioteque Corp.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 202
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