Cleared Traditional

K090502 - NOVA SAFE SCALP VEIN BLOOD COLLECTION SET

K090502 is an FDA 510(k) clearance for NOVA SAFE SCALP VEIN BLOOD COLLECTION SET, manufactured by U.S. Safety Syringes Co., Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K090502 · U.S. Safety Syringes Co., Inc. · General Hospital
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Mar 2009
Decision
13d
Days
Class 2
Risk

K090502 is an FDA 510(k) clearance for the NOVA SAFE SCALP VEIN BLOOD COLLECTION SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by U.S. Safety Syringes Co., Inc. (Crofton, US). The FDA issued a Cleared decision on March 10, 2009 after a review of 13 days - a notably fast clearance 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: 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 U.S. Safety Syringes Co., Inc. devices

FDA 510(k) Submission Details - K090502

510(k) Number K090502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date March 10, 2009
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 351
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