Cleared Traditional

MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C (K043600) - FDA 510(k) Clearance

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

K043600 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
90d
Days
Class 2
Risk

K043600 is an FDA 510(k) clearance for the MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on March 29, 2005 after a review of 90 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 K043600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date March 29, 2005
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K043600.
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
K052973 · Baxter Healthcare Corp · Jan 2007
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
K052171 · Zimmer, Inc. · Oct 2005
PUMP CONNECTIVITY INTERFACE
K040985 · Baxter Healthcare Corp · Nov 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004