Cleared Special

K220756 - Introcan Safety 2 IV Catheter

K220756 is an FDA 510(k) clearance for Introcan Safety 2 IV Catheter, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 100-day FDA review.

K220756 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
100d
Days
Class 2
Risk

K220756 is an FDA 510(k) clearance for the Introcan Safety 2 IV Catheter. 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 June 23, 2022 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K220756

510(k) Number K220756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2022
Decision Date June 23, 2022
Days to Decision 100 days
Submission Type Special
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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 K220756.
HydroMID 4F Single Lumen Midline Catheter
K220772 · Access Vascular, Inc. · Dec 2022
MagiCath II
K210929 · Woo Young Medical Co., Ltd. · Sep 2022
Leaderflex Mini and Leaderflex Nano
K212370 · Vygon USA · Aug 2022
Introcan Safety IV Catheter
K220626 · B.Braun Medical, Inc. · May 2022
BD Cathena Safety IV Catheter
K220584 · Becton Dickinson Infusion Therapy Systems, Inc. · Mar 2022
Pluski Safe 1 Safety IV Catheter
K210037 · Mediplus (India) Limited · Mar 2022
K220756 · Introcan Safety 2 IV Catheter
Download PDF FDA Summary B.Braun Medical, Inc.