Cleared Traditional

V SET (K020424) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020424 · Hennig Enterprises Europe Srl · General Hospital
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Aug 2003
Decision
567d
Days
Class 2
Risk

K020424 is an FDA 510(k) clearance for the V SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Hennig Enterprises Europe Srl (Perth, AU). The FDA issued a Cleared decision on August 29, 2003 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Hennig Enterprises Europe Srl devices

Submission Details

510(k) Number K020424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2002
Decision Date August 29, 2003
Days to Decision 567 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
438d slower than avg
Panel avg: 129d · This submission: 567d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
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