Cleared Traditional

K011860 - KEYST0NE MEDICAL PICC CATHETER

K011860 is an FDA 510(k) clearance for KEYST0NE MEDICAL PICC CATHETER, manufactured by Keystone Medical. 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.

K011860 · Keystone Medical · General Hospital
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Jun 2001
Decision
13d
Days
Class 2
Risk

K011860 is an FDA 510(k) clearance for the KEYST0NE MEDICAL PICC CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Keystone Medical (Great Neck, US). The FDA issued a Cleared decision on June 27, 2001 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 Keystone Medical devices

FDA 510(k) Submission Details - K011860

510(k) Number K011860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date June 27, 2001
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 279
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