Cleared Traditional

MULTI-DRIP INFUSION CATHETER (K042246) - FDA 510(k) Clearance

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

K042246 · Advanced Infusion, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
12d
Days
Class 2
Risk

K042246 is an FDA 510(k) clearance for the MULTI-DRIP INFUSION CATHETER. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Advanced Infusion, Inc. (Tempe, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Advanced Infusion, Inc. devices

Submission Details

510(k) Number K042246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2004
Decision Date August 31, 2004
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEB Pump, Infusion, Elastomeric

All 87
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K042246.
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