Cleared Traditional

K874564 - MINIMED III INFUSION PUMP & UNI-SET ADMIN SET

K874564 is an FDA 510(k) clearance for MINIMED III INFUSION PUMP & UNI-SET ADM..., manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K874564

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K874564.
MODIFIED PCA INFUSER
K875364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
RATEMINDER V INFUSION PUMP
K875174 · Critikon Company, LLC · Mar 1988
BAXTER BEDSIDE SYSTEM
K874181 · Travenol Laboratories, S.A. · Feb 1988
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
K874649 · Pharmacia Deltec, Inc. · Jan 1988
MODEL 3000 INFUSION PUMP
K871881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · Baxter Healthcare Corp · Jan 1988