Cleared Traditional

K944665 - DIB INFUSORS

K944665 is an FDA 510(k) clearance for DIB INFUSORS, manufactured by Novacon Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K944665 · Novacon Corp. · General Hospital
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Feb 1995
Decision
155d
Days
Class 2
Risk

K944665 is an FDA 510(k) clearance for the DIB INFUSORS. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Novacon Corp. (St. Paul, US). The FDA issued a Cleared decision on February 14, 1995 after a review of 155 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 Novacon Corp. devices

FDA 510(k) Submission Details - K944665

510(k) Number K944665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 12, 1994
Decision Date February 14, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
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 49
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K944665.
TITAN 20 CC DRIVER
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INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
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K922382 · Baxter Healthcare Corp · Feb 1993
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658 · Imed Corp. · Mar 1992