Cleared Traditional

K190855 - BD Acute Central Line

K190855 is the FDA 510(k) clearance for BD Acute Central Line by Bard Access Systems, Inc. (Bard Has Joined Bd). It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K190855 · Bard Access Systems, Inc. (Bard Has Joined Bd) · General Hospital
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Nov 2019
Decision
213d
Days
Class 2
Risk

K190855 is an FDA 510(k) clearance for the BD Acute Central Line. 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 November 1, 2019 after a review of 213 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. (Bard Has Joined Bd) devices

Submission Details

510(k) Number K190855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2019
Decision Date November 01, 2019
Days to Decision 213 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 129d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K190855.
Health Line CT Midline Catheter
K200263 · Health Line International Corporation · Mar 2020
BD Cathena (TM) Safety IV Catheter
K192493 · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 2020
Health Line CT CVC
K192533 · Health Line International Corporation · Dec 2019
Supercath 5
K190001 · Togo Medikit Co., Ltd. · Sep 2019
AccuCath Ace Intravascular Catheter
K191232 · C.R. Bard, Inc. · Sep 2019
Cook Unimpregnated Central Venous Catheter
K182252 · Cook Incorporated · May 2019

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.