Cleared Traditional

K192676 - Introcan Safety 2 IV Catheter 18-24 gauge

K192676 is an FDA 510(k) clearance for Introcan Safety 2 IV Catheter 18-24 gauge, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K192676 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
188d
Days
Class 2
Risk

K192676 is an FDA 510(k) clearance for the Introcan Safety 2 IV Catheter 18-24 gauge. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on April 1, 2020 after a review of 188 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K192676

510(k) Number K192676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date April 01, 2020
Days to Decision 188 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
59d slower than avg
Panel avg: 129d · This submission: 188d
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 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K192676.
MedSource CathMED IV Catheter
K193278 · Medsource Labs · Aug 2020
MF SAFECATH
K192230 · Medifirst Co., Ltd. · Apr 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266 · Bard Access Systems, Inc. (Bard Has Joined Bd) · Apr 2020
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