Cleared Special

K213664 - B. Braun Introcan Safety 2 IV Catheter

K213664 is the FDA 510(k) clearance for B. Braun Introcan Safety 2 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 81-day FDA review.

K213664 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
81d
Days
Class 2
Risk

K213664 is an FDA 510(k) clearance for the B. Braun 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 February 11, 2022 after a review of 81 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 K213664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date February 11, 2022
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K213664.
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
Introcan Safety 3 Closed IV Catheter
K213085 · B.Braun Medical, Inc. · Oct 2021
Disposable IV catheter
K202060 · Shinva Ande Healthcare Apparatus Co., Ltd. · Jul 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
K200891 · Becton, Dickinson and Company · Jun 2021