Cleared Traditional

K040676 - MEDTRONIC MINIMED PARADIGM INSULIN PUMP

K040676 is the FDA 510(k) clearance for MEDTRONIC MINIMED PARADIGM INSULIN PUMP by Medtronic Minimed. It is a Class 2 General Hospital device (product code LZG) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K040676 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
67d
Days
Class 2
Risk

K040676 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 67 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 K040676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2004
Decision Date May 21, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 29
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K040676.
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760 · Roche Diagnostics Corp. · Sep 2005
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · Medtronic Minimed · Jul 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · Medtronic Minimed · Jul 2004
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999
MINIMED 508 INSULIN PUMP
K990801 · Medtronic Minimed · Jun 1999