Cleared Traditional

K151698 - BD Angiocath IV Catheter, BD Insyte IV Catheter

K151698 is an FDA 510(k) clearance for BD Angiocath IV Catheter, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K151698 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
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Jul 2015
Decision
33d
Days
Class 2
Risk

K151698 is an FDA 510(k) clearance for the BD Angiocath IV Catheter, BD Insyte IV Catheter. 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 July 27, 2015 after a review of 33 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K151698

510(k) Number K151698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2015
Decision Date July 27, 2015
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 129d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K151698.
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
K160374 · Tangent Medical Technologies, Inc. · Mar 2016
AccuCath Intravascular Catheter
K153298 · C.R. Bard, Inc. · Dec 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · Nov 2015
MedSource ClearSafe Safety IV Catheter
K150611 · Medsource International · Jul 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K151513 · Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) · Jul 2015
I.V. Catheter
K142797 · Jiangxi Sanxin Medtec Co., Ltd. · Jun 2015

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.