Cleared Traditional

K813083 - VENOFIX SCALP VEIN SET

K813083 is the FDA 510(k) clearance for VENOFIX SCALP VEIN SET by Burron Medical Products, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K813083 · Burron Medical Products, Inc. · General Hospital
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Nov 1981
Decision
14d
Days
Class 2
Risk

K813083 is an FDA 510(k) clearance for the VENOFIX SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 14 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K813083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date November 16, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 307
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K813083.
CLIRANS PRIMING SET
K820788 · Terumo Medical Corp. · Apr 1982
INTRAVASCULAR ADMINISTRATION SET
K820278 · Y · Feb 1982
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · Baxter Healthcare Corp · Dec 1981
QI 1150-1T INFUSION T
K812688 · Quinton, Inc. · Oct 1981
30-30-2 700 SYRINGE EXTENSION SET
K811885 · Y · Aug 1981
INTRAVENOUS ADMINISTRATION SET
K812231 · Cordis Corp. · Aug 1981