Cleared Special

K213085 - Introcan Safety 3 Closed IV Catheter

K213085 is the FDA 510(k) clearance for Introcan Safety 3 Closed 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 31-day FDA review.

K213085 · B.Braun Medical, Inc. · General Hospital
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Oct 2021
Decision
31d
Days
Class 2
Risk

K213085 is an FDA 510(k) clearance for the Introcan Safety 3 Closed 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 October 25, 2021 after a review of 31 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 K213085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date October 25, 2021
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 K213085.
BD Cathena Safety IV Catheter
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BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
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HydroMID
K203069 · Access Vascular, Inc. · Feb 2021