Cleared Traditional

K914148 - PRIME CADI-120

K914148 is an FDA 510(k) clearance for PRIME CADI-120, manufactured by Prime Medical Products, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K914148 · Prime Medical Products, Inc. · General Hospital
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Oct 1992
Decision
385d
Days
Class 2
Risk

K914148 is an FDA 510(k) clearance for the PRIME CADI-120. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Prime Medical Products, Inc. (Windermere, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Prime Medical Products, Inc. devices

FDA 510(k) Submission Details - K914148

510(k) Number K914148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date October 05, 1992
Days to Decision 385 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
256d slower than avg
Panel avg: 129d · This submission: 385d
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.