Cleared Traditional

K012526 - BIOTEQUE SCALP VEIN SET

K012526 is the FDA 510(k) clearance for BIOTEQUE SCALP VEIN SET by Bioteque Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K012526 · Bioteque Corp. · General Hospital
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Sep 2001
Decision
39d
Days
Class 2
Risk

K012526 is an FDA 510(k) clearance for the BIOTEQUE SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Bioteque Corp. (Flaggstaff, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioteque Corp. devices

Submission Details

510(k) Number K012526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date September 14, 2001
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 375
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K012526.
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
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SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
TAXOL ADMINISTRATION SET
K003513 · Icu Medical, Inc. · Jan 2001