Cleared Traditional

K011297 - NIPRO SAFETOUCH SCALP VEIN AND BLOOD CO...

K011297 is the FDA 510(k) clearance for NIPRO SAFETOUCH SCALP VEIN AND BLOOD CO... by Nipro Medical Corp.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K011297 · Nipro Medical Corp. · General Hospital
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Jun 2001
Decision
51d
Days
Class 2
Risk

K011297 is an FDA 510(k) clearance for the NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on June 20, 2001 after a review of 51 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 Nipro Medical Corp. devices

Submission Details

510(k) Number K011297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2001
Decision Date June 20, 2001
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 274
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