Cleared Traditional

K233106 - AccuCath Ace Intravascular Catheter

K233106 is the FDA 510(k) clearance for AccuCath Ace Intravascular Catheter by Bard Access Systems, Inc. (C.R. Bard, Inc.). It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K233106 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · General Hospital
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Apr 2024
Decision
205d
Days
Class 2
Risk

K233106 is an FDA 510(k) clearance for the AccuCath Ace™ Intravascular Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (C.R. Bard, Inc.) (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 205 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bard Access Systems, Inc. (C.R. Bard, Inc.) devices

Submission Details

510(k) Number K233106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date April 19, 2024
Days to Decision 205 days
Submission Type Traditional
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
76d slower than avg
Panel avg: 129d · This submission: 205d
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 240
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