Cleared Traditional

K941766 - DIB INFUSOR

K941766 is an FDA 510(k) clearance for DIB INFUSOR, 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 116-day FDA review.

K941766 · Novacon Corp. · General Hospital
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Aug 1994
Decision
116d
Days
Class 2
Risk

K941766 is an FDA 510(k) clearance for the DIB INFUSOR. 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 August 5, 1994 after a review of 116 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 Novacon Corp. devices

FDA 510(k) Submission Details - K941766

510(k) Number K941766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 11, 1994
Decision Date August 05, 1994
Days to Decision 116 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
13d faster than avg
Panel avg: 129d · This submission: 116d
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 K941766.
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