Cleared Traditional

K864138 - MINIMED MODEL 404-S EXTERNAL INFUSION PUMP

K864138 is the FDA 510(k) clearance for MINIMED MODEL 404-S EXTERNAL INFUSION PUMP by Medtronic Minimed. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K864138 · Medtronic Minimed · General Hospital
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Dec 1986
Decision
69d
Days
Class 2
Risk

K864138 is an FDA 510(k) clearance for the MINIMED MODEL 404-S EXTERNAL INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on December 29, 1986 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Minimed devices

Submission Details

510(k) Number K864138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date December 29, 1986
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 437
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K864138.
STRATO(R) PCA INFUSER
K864808 · Strato Medical Corp. · Jan 1987
PERCUPUMP (TM)
K864227 · E-Z-Em, Inc. · Jan 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · C.R. Bard, Inc. · Jan 1987
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · Medtronic Minimed · Dec 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 1986