Cleared Traditional

K192493 - BD Cathena (TM) Safety IV Catheter

K192493 is an FDA 510(k) clearance for BD Cathena (TM) Safety IV Catheter, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K192493 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
135d
Days
Class 2
Risk

K192493 is an FDA 510(k) clearance for the BD Cathena (TM) Safety IV Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on January 24, 2020 after a review of 135 days - within the typical 510(k) review window.

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 - K192493

510(k) Number K192493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date January 24, 2020
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 K192493.
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Apr 2020
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · B.Braun Medical, Inc. · Apr 2020
Health Line CT Midline Catheter
K200263 · Health Line International Corporation · Mar 2020
Health Line CT CVC
K192533 · Health Line International Corporation · Dec 2019
BD Acute Central Line
K190855 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Nov 2019
Supercath 5
K190001 · Togo Medikit Co., Ltd. · Sep 2019
K192493 · BD Cathena (TM) Safety IV Catheter
Download PDF FDA Summary Becton Dickinson Infu…