Cleared Special

K233529 - BD Nexiva Diffusics Closed IV Catheter ...

K233529 is the FDA 510(k) clearance for BD Nexiva Diffusics Closed IV Catheter ... by Becton Dickinson Infusion Therapy Systems, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K233529 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
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Dec 2023
Decision
29d
Days
Class 2
Risk

K233529 is an FDA 510(k) clearance for the BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free .... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on December 1, 2023 after a review of 29 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 Becton Dickinson Infusion Therapy Systems, Inc. devices

Submission Details

510(k) Number K233529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2023
Decision Date December 01, 2023
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K233529.
Introcan Safety® 2 IV Catheter
K241845 · B.Braun Medical, Inc. · Jul 2024
AccuCath Ace™ Intravascular Catheter
K233106 · Bard Access Systems, Inc. (C.R. Bard, Inc.) · Apr 2024
Nouvo Safety Set
K232234 · Poly Medicure Limited · Mar 2024
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
K231401 · Poly Medicure Limited · Sep 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
K223788 · Medsource International, LLC · Sep 2023