Cleared Special

K010034 - DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

K010034 is an FDA 510(k) clearance for DOUBLE LUMEN URETHANE PICC LINE, manufactured by Cook, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 20-day FDA review.

K010034 · Cook, Inc. · General Hospital
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Jan 2001
Decision
20d
Days
Class 2
Risk

K010034 is an FDA 510(k) clearance for the DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 24, 2001 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K010034

510(k) Number K010034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2001
Decision Date January 24, 2001
Days to Decision 20 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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

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