Cleared Traditional

IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT (K961486) - FDA 510(k) Clearance

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

K961486 · Ivac Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
732d
Days
Class 2
Risk

K961486 is an FDA 510(k) clearance for the IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Ivac Medical Systems (San Diego, US). The FDA issued a Cleared decision on April 17, 1998 after a review of 732 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Ivac Medical Systems devices

Submission Details

510(k) Number K961486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date April 17, 1998
Days to Decision 732 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
603d slower than avg
Panel avg: 129d · This submission: 732d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRZ Accessories, Pump, Infusion
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.