Cleared Traditional

K864327 - MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP (FDA 510(k) Clearance)

Class I General Hospital device.

K864327 · Medtronic Minimed · General Hospital
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Feb 1987
Decision
94d
Days
Class 1
Risk

K864327 is an FDA 510(k) clearance for the MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 K864327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date February 06, 1987
Days to Decision 94 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
34d faster than avg
Panel avg: 128d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.