Cleared Traditional

K983634 - PREPARE HOME INFUSION PUMP

K983634 is an FDA 510(k) clearance for PREPARE HOME INFUSION PUMP, manufactured by Medical Infusion Technologies, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K983634

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.

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 33
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K983634.
DISPOSABLE INFUSION PUMP KIT
K993972 · Biomet, Inc. · Feb 2000
INTRAOP CATHETER
K991543 · I-Flow Corp. · Oct 1999
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999
PAINBUSTER INFUSION KIT
K982946 · I-Flow Corp. · Nov 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102 · Baxter Healthcare Corp · Sep 1998
PAINBUSTER INFUSION SYSTEM
K980558 · I-Flow Corp. · May 1998