Cleared Traditional

K914378 - PERIPHERAL INTERVENOUS CATHETER

K914378 is an FDA 510(k) clearance for PERIPHERAL INTERVENOUS CATHETER, manufactured by Medical Profiles, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 597-day FDA review.

K914378 · Medical Profiles, Inc. · General Hospital
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May 1993
Decision
597d
Days
Class 2
Risk

K914378 is an FDA 510(k) clearance for the PERIPHERAL INTERVENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medical Profiles, Inc. (Lavonia, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 597 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medical Profiles, Inc. devices

FDA 510(k) Submission Details - K914378

510(k) Number K914378 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 01, 1991
Decision Date May 20, 1993
Days to Decision 597 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
468d slower than avg
Panel avg: 129d · This submission: 597d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 422
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