Cleared Traditional

K233106 - AccuCath Ace™ Intravascular Catheter

K233106 is an FDA 510(k) clearance for AccuCath Ace Intravascular Catheter, manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). The device is a Class 2 General Hospital device with 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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K233106

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.

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 507
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K233106.
SV Spectrum MRC Central Venous Catheter
K241115 · Spectrum Vascular · Nov 2024
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K240359 · Becton, Dickinson and Company (Bard Access Systems, Inc.) · Jul 2024
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Nouvo Safety Set
K232234 · Poly Medicure Limited · Mar 2024
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K233529 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 2023
K233106 · AccuCath Ace™ Intravascular Catheter
Download PDF FDA Summary Bard Access Systems, …