Cleared Abbreviated

K052389 - I-PORT

K052389 is an FDA 510(k) clearance for I-PORT, manufactured by Patton Medical Devices. The device is a Class 2 General Hospital device with product code FOZ cleared through the Abbreviated 510(k) pathway after a 9-day FDA review.

K052389 · Patton Medical Devices · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
9d
Days
Class 2
Risk

K052389 is an FDA 510(k) clearance for the I-PORT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Patton Medical Devices (Eagle, US). The FDA issued a Cleared decision on September 9, 2005 after a review of 9 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052389

510(k) Number K052389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date September 09, 2005
Days to Decision 9 days
Submission Type Abbreviated
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
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Standards-based clearance path. 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

Tuv America, Inc.
LAURA DANIELSON

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 492
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K052389.
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
K042504 · Myco Medical Supplies, Inc. · Jan 2006
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
K053120 · Excelsior Medical Corp. · Dec 2005
VANISHPOINT I.V. CATHETER
K051355 · Retractable Technologies, Inc. · Sep 2005
SUPERCATH Z3V
K050114 · Togo Medikit Co., Ltd. · Jun 2005
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
K043446 · Emmebi Srl · Feb 2005
BD ONECATH
K042862 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2004

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.

K052389 · I-PORT
Download PDF FDA Summary Patton Medical Devices