Cleared Special

K200266 - BD Centro Vena Acute Central Line (7 Fr...

K200266 is the FDA 510(k) clearance for BD Centro Vena Acute Central Line (7 Fr... by Bard Access Systems, Inc. (Bard Has Joined Bd). It is a Class 2 General Hospital device (product code FOZ) cleared through the Special 510(k) pathway after a 64-day FDA review.

K200266 · Bard Access Systems, Inc. (Bard Has Joined Bd) · General Hospital
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Apr 2020
Decision
64d
Days
Class 2
Risk

K200266 is an FDA 510(k) clearance for the BD Centro Vena Acute Central Line (7 French Dual Lumen). Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 7, 2020 after a review of 64 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 Bard Access Systems, Inc. (Bard Has Joined Bd) devices

Submission Details

510(k) Number K200266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date April 07, 2020
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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

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