Medical Device Manufacturer · US , Northridge , CA

Medtronic Minimed

48 submissions · 43 cleared · Since 1986
48
Total
43
Cleared
0
Denied

Medtronic Minimed — FDA 510(k) Submissions

Medtronic Minimed has submitted 48 FDA 510(k) premarket notifications since 1986, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Infusion, Insulin, Pump, Infusion, Set, Administration, Intravascular, Introducer, Syringe Needle, Tubing, Fluid Delivery . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
SmartGuard Technology; Predictive Low Glucose Technology
K253701 · QJI Interoperable Automated... · Chemistry
Feb 2026 71d
MiniMed Go App
K253512 · NDC Calculator, Drug Dose · Chemistry
Jan 2026 63d
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC Calculator, Drug Dose · Chemistry
Nov 2024 60d
Extended Reservoir; MiniMed Reservoir
K241622 · LZG Pump, Infusion, Insulin · Chemistry
Jul 2024 27d
MiniMed Quick-serter
K160860 · KZH Introducer, Syringe Needle · General Hospital
Sep 2016 177d
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · LZG Pump, Infusion, Insulin · General Hospital
Mar 2012 66d
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
K100432 · FPA Set, Administration,... · General Hospital
Jul 2010 143d
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
K073356 · LZG Pump, Infusion, Insulin · General Hospital
Apr 2008 148d
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · LZG Pump, Infusion, Insulin · General Hospital
Jan 2006 78d
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
K052431 · FPK Tubing, Fluid Delivery · General Hospital
Nov 2005 84d
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
K052432 · FPA Set, Administration,... · General Hospital
Nov 2005 84d
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · FRN Pump, Infusion · General Hospital
Mar 2005 90d
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317 · LZG Pump, Infusion, Insulin · General Hospital
Jul 2004 62d
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · LZG Pump, Infusion, Insulin · General Hospital
Jul 2004 62d
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · LZG Pump, Infusion, Insulin · General Hospital
May 2004 67d
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · FRN Pump, Infusion · General Hospital
Apr 2004 86d
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · FPA Set, Administration,... · General Hospital
Oct 2003 77d
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · FPA Set, Administration,... · General Hospital
Oct 2003 77d
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · LZG Pump, Infusion, Insulin · General Hospital
Oct 2003 100d
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · FRN Pump, Infusion · General Hospital
Aug 2003 53d
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
K031917 · FPA Set, Administration,... · General Hospital
Aug 2003 57d
3.0 ML RESERVOIR, MODEL 103/193
K991936 · FRN Pump, Infusion · General Hospital
Jan 2000 223d
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
K993012 · LZG Pump, Infusion, Insulin · General Hospital
Nov 1999 68d
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979 · FPA Set, Administration,... · General Hospital
Sep 1999 81d
QUICK-SERTER, MODEL 395
K992300 · KZH Introducer, Syringe Needle · General Hospital
Jul 1999 21d
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