Cleared Traditional

K040427 - FIBREX CATHETER PATENCY DEVICE

K040427 is an FDA 510(k) clearance for FIBREX CATHETER PATENCY DEVICE, manufactured by Medical Device Technologies, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K040427 · Medical Device Technologies, Inc. · General Hospital
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May 2004
Decision
74d
Days
Class 2
Risk

K040427 is an FDA 510(k) clearance for the FIBREX CATHETER PATENCY DEVICE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 3, 2004 after a review of 74 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 Medical Device Technologies, Inc. devices

FDA 510(k) Submission Details - K040427

510(k) Number K040427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2004
Decision Date May 03, 2004
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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

Entela, Inc.
NED DEVINE

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 416
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K040427.
BD ONECATH
K042862 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · Cook, Inc. · Aug 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
K041345 · Medix, Inc. · Jul 2004
NEXIVA CLOSED IV CATHETER SYSTEM
K032843 · Becton Dickinson Infusion Therapy Systems, Inc. · Feb 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · Cook, Inc. · Feb 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · Becton, Dickinson & CO · Jan 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.