Cleared Traditional

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715

K040676 · Medtronic Minimed · General Hospital
May 2004
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K040676 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on May 21, 2004, 67 days after receiving the submission on March 15, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K040676 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — LZG Pump, Infusion, Insulin

All 82
Modular Medical MODD1 Insulin Delivery System
K240158 · Modular Medical, Inc. · Sep 2024
Extended Reservoir; MiniMed Reservoir
K241622 · Medtronic Minimed · Jul 2024
Omnipod GO Insulin Delivery Device
K223372 · Insulet Corporation · Apr 2023
Extended Reservoir
K210714 · Medtronic Minimed, Inc. · Apr 2022
Omnipod? Insulin Management System, Omnipod DASH? Insulin Management System
K211575 · Insulet Corporation · Aug 2021
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · Insulet Corporation · Oct 2019