Cleared Traditional

ALPHA INFUSION PUMP, MODEL A200, A450 (K071532) - FDA 510(k) Clearance

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

K071532 · Advanced Infusion, Inc. · General Hospital
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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.

View all Advanced Infusion, Inc. devices

Submission Details

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
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.

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 K071532.
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ON-Q* Pump with Bolus
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INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · Baxter Healthcare Corp · May 2002