Cleared Traditional

PREPARE HOME INFUSION PUMP (K983634) - FDA 510(k) Clearance

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

K983634 · Medical Infusion Technologies, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
132d
Days
Class 2
Risk

K983634 is an FDA 510(k) clearance for the PREPARE HOME INFUSION PUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Medical Infusion Technologies, Inc. (Orchard Park, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 132 days - within the typical 510(k) review window.

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 Medical Infusion Technologies, Inc. devices

Submission Details

510(k) Number K983634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date February 24, 1999
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 K983634.
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K052999 · Ethicon, Inc. · Mar 2006