Cleared Traditional

K071532 - ALPHA INFUSION PUMP, MODEL A200, A450

K071532 is an FDA 510(k) clearance for ALPHA INFUSION PUMP, manufactured by Advanced Infusion, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K071532 · Advanced Infusion, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
259d
Days
Class 2
Risk

K071532 is an FDA 510(k) clearance for the ALPHA INFUSION PUMP, MODEL A200, A450. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Advanced Infusion, Inc. (San Dimas, US). The FDA issued a Cleared decision on February 19, 2008 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K071532

510(k) Number K071532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date February 19, 2008
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEB Device Classification - Class 2, Special Controls

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 K071532.
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K072921 · Symbios Medical Products, LLC · Nov 2007
SMARTBLOCK PAIN PUMP
K072053 · Medical Flow Systems, Ltd. · Nov 2007
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
K071735 · Symbios Medical Products, LLC · Jul 2007
K071532 · ALPHA INFUSION PUMP, MODEL A200, A450
Download PDF FDA Summary Advanced Infusion, In…