Cleared Traditional

K874564 - MINIMED III INFUSION PUMP & UNI-SET ADMIN SET (FDA 510(k) Clearance)

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

K874564 · Medtronic Minimed · General Hospital
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Feb 1988
Decision
99d
Days
Class 2
Risk

K874564 is an FDA 510(k) clearance for the MINIMED III INFUSION PUMP & UNI-SET ADMIN SET. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 99 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 Medtronic Minimed devices

Submission Details

510(k) Number K874564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1987
Decision Date February 11, 1988
Days to Decision 99 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
29d faster than avg
Panel avg: 128d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN 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.

Regulatory Peers - FRN Pump, Infusion

All 847
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