Cleared Special

K220626 - Introcan Safety IV Catheter

K220626 is the FDA 510(k) clearance for Introcan Safety IV Catheter by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Special 510(k) pathway after a 71-day FDA review.

K220626 · B.Braun Medical, Inc. · General Hospital
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May 2022
Decision
71d
Days
Class 2
Risk

K220626 is an FDA 510(k) clearance for the Introcan Safety 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 May 14, 2022 after a review of 71 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K220626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2022
Decision Date May 14, 2022
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 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 K220626.
MagiCath II
K210929 · Woo Young Medical Co., Ltd. · Sep 2022
Leaderflex Mini and Leaderflex Nano
K212370 · Vygon USA · Aug 2022
Introcan Safety 2 IV Catheter
K220756 · B.Braun Medical, Inc. · Jun 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
B. Braun Introcan Safety 2 IV Catheter
K213664 · B.Braun Medical, Inc. · Feb 2022