Cleared Traditional

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 (K061356) - FDA 510(k) Clearance

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

K061356 · Advanced Infusion, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
49d
Days
Class 2
Risk

K061356 is an FDA 510(k) clearance for the POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INF.... Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Advanced Infusion, Inc. (Tempe, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 K061356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date July 03, 2006
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 63
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