Company ยท US
Medtronic Minimed
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2026. Name variants (Inc, Corp, punctuation) are merged.
57510(k) clearances (6 in 12 months)
99recalls (26 in 12 months)
29recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZG | Pump, Infusion, Insulin | 32 |
| OYC | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | 32 |
| FPA | Set, Administration, Intravascular | 17 |
| OZP | Automated Insulin Dosing Device System, Single Hormonal Control | 17 |
| FRN | Pump, Infusion | 16 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 9 |
| NDC | Calculator, Drug Dose | 6 |
| OZO | Automated Insulin Dosing , Threshold Suspend | 5 |
| MDS | Sensor, Glucose, Invasive | 4 |
| QJI | Interoperable Automated Glycemic Controller | 4 |
| KZH | Introducer, Syringe Needle | 3 |
| FPK | Tubing, Fluid Delivery | 2 |
| N/A | 2 | |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 2 |
| FMF | Syringe, Piston | 1 |
| FRW | Scale, Patient | 1 |
| MRZ | Accessories, Pump, Infusion | 1 |
| OUG | Medical Device Data System | 1 |
| PJT | Continuous Glucose Monitor Secondary Display | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2026 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology Medtronic MiniMed | QJI |
| Mar 12, 2026 | K253743 | MiniMed Flex pump Medtronic Minimed, Inc. | QFG |
| Feb 3, 2026 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology Medtronic Minimed | QJI |
| Jan 15, 2026 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) Medtronic Minimed, Inc. | QFG |
| Jan 14, 2026 | K253585 | SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed, Inc. | QJI |
| Jan 8, 2026 | K253512 | MiniMed Go App Medtronic Minimed | NDC |
| Aug 29, 2025 | K251217 | SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed, Inc. | QJI |
| Jul 1, 2025 | K251032 | MiniMed 780G insulin pump Medtronic Minimed, Inc. | QFG |
| Nov 12, 2024 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) Medtronic Minimed | NDC |
| Jul 2, 2024 | K241622 | Extended Reservoir; MiniMed Reservoir Medtronic Minimed | LZG |
| Apr 6, 2022 | K210714 | Extended Reservoir Medtronic Minimed, Inc. | LZG |
| Sep 22, 2016 | K160860 | MiniMed Quick-serter Medtronic Minimed | KZH |
| May 19, 2015 | K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) Medtronic Minimed, Inc. | PJT |
| Mar 29, 2012 | K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS Medtronic Minimed | LZG |
| Jul 9, 2010 | K100432 | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS Medtronic Minimed | FPA |
| Apr 25, 2008 | K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 Medtronic Minimed | LZG |
| Oct 17, 2007 | K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 Medtronic Minimed, Inc. | MRZ |
| Jan 31, 2006 | K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E Medtronic Minimed | LZG |
| Nov 29, 2005 | K052432 | MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 Medtronic Minimed | FPA |
| Nov 29, 2005 | K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 Medtronic Minimed | FPK |
| Mar 29, 2005 | K043600 | MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C Medtronic Minimed | FRN |
| Jul 19, 2004 | K041318 | MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP Medtronic Minimed | LZG |
| Jul 19, 2004 | K041317 | MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP Medtronic Minimed | LZG |
| May 21, 2004 | K040676 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 Medtronic Minimed | LZG |
| Apr 8, 2004 | K040061 | MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C Medtronic Minimed | FRN |
| Oct 28, 2003 | K032485 | MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313 Medtronic Minimed | FPA |
| Oct 28, 2003 | K032484 | MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310 Medtronic Minimed | FPA |
| Oct 23, 2003 | K032164 | DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 Medtronic Minimed | LZG |
| Aug 22, 2003 | K032005 | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 Medtronic Minimed | FRN |
| Aug 19, 2003 | K031917 | MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S Medtronic Minimed | FPA |
| Jan 18, 2000 | K991936 | 3.0 ML RESERVOIR, MODEL 103/193 Medtronic Minimed | FRN |
| Nov 15, 1999 | K993012 | MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 Medtronic Minimed | LZG |
| Sep 3, 1999 | K991979 | SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 Medtronic Minimed | FPA |
| Jul 29, 1999 | K992300 | QUICK-SERTER, MODEL 395 Medtronic Minimed | KZH |
| Jun 23, 1999 | K991013 | MINIMED 407C INFUSION PUMP, MODEL 407C Medtronic Minimed | FRN |
| Jun 8, 1999 | K990801 | MINIMED 508 INSULIN PUMP Medtronic Minimed | LZG |
| Feb 2, 1998 | K974163 | MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 Medtronic Minimed | FPA |
| Aug 15, 1997 | K972107 | MINIMED INFUSION PUMP, MODEL 507C Medtronic Minimed | LZG |
| Apr 8, 1997 | K963948 | MINIMED INSULIN PUMP, MODEL 505 Medtronic Minimed | LZG |
| Mar 31, 1997 | K970479 | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 Medtronic Minimed | KZH |
| Feb 26, 1997 | K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 Medtronic Minimed | FPK |
| Jan 30, 1997 | K964456 | POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 Medtronic Minimed | FPA |
| Jan 30, 1997 | K964455 | POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 Medtronic Minimed | FPA |
| May 6, 1996 | K961474 | POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133 Medtronic Minimed | FPA |
| Apr 30, 1996 | K960001 | MINIMED INFUSION PUMP, MODEL MMT-507 Medtronic Minimed | LZG |
| Feb 22, 1996 | K954969 | POLYFIN QR SUBCUTANEOUS INFUSION SET Medtronic Minimed | FPA |
| Jul 14, 1994 | K942181 | SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 Medtronic Minimed | FPA |
| Sep 16, 1993 | K922670 | THE MINIMED MODEL 404-SP AND 504-S Medtronic Minimed | FRN |
| Jun 24, 1991 | K912458 | MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED Medtronic Minimed | FRN |
| Jul 2, 1990 | K901588 | MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP Medtronic Minimed | LZG |
Newest 50 of 57.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medtronic MiniMed, Inc. Generic Name: MiniMed Go App
Generic Name: MiniMed Go App
Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android)
Software Version: Software version 1.2.1
Product Description: The MiniMed Go app for Open, Classified |
NDC | K253512 |
| Oct 21, 2026 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Oct 5, 2026 | Medtronic MiniMed, Inc. Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump inte Open, Classified |
QFG | K253743 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW Open, Classified |
QFG | K251032 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; Open, Classified |
OZP | None listed |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; Open, Classified |
QFG | K251032 |
| Jul 23, 2026 | Medtronic MiniMed, Inc. MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) Open, Classified |
NDC | K253512 |
| Jul 8, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 Open, Classified |
QFG | K251032 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) Open, Classified |
N/A | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 530G Insulin Pump (MMT-551, MMT-751) Open, Classified |
OZO | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm Insulin Pump (MMT-712, MMT-715) Open, Classified |
LZG | K031390 K040676 +2 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 620G Insulin Pump (MMT-1750) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) Open, Classified |
N/A | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) Open, Classified |
OYC | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) Open, Classified |
OZP | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) Open, Classified |
QFG | K251032 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) Open, Classified |
OZO | None listed |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) Open, Classified |
OZP | None listed |
| Mar 24, 2026 | Medtronic MiniMed, Inc. MiniMed" 780G - MMT-1884
MiniMed" 780G - MMT-1886
With Software 6.60 and 6.61 Open, Classified |
QFG | K251032 |
| Feb 2, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump Catalog Numbers:
MMT-1884
MMT-1886
With Software Version 6.60
The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total Open, Classified |
OZP | K251032 |
| Dec 18, 2025 | Medtronic MiniMed, Inc. InPen App, Model/CFN Number: MMT-8061 (Android Users) Open, Classified |
NDC | K242775 |
| Nov 25, 2025 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Oct 2, 2025 | Medtronic MiniMed, Inc. Medtronic, Simplera Sensor, REF: MMT-5100JD1 Open, Classified |
MDS | None listed |
| Sep 2, 2025 | Medtronic MiniMed, Inc. InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Open, Classified |
NDC | K242775 |
| Apr 21, 2025 | Medtronic MiniMed, Inc. InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA Open, Classified |
FMF | K160629 K190487 +3 |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) Open, Classified |
OZP | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) Open, Classified |
OZP | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) Open, Classified |
OZP | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) Open, Classified |
OZP | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) Open, Classified |
OZO | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. MiniMed insulin pump, REF: 620G (MMT-1750) Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. Paradigm insulin pump, REF: MMT-754 Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751 Open, Classified |
OYC | None listed |
| Mar 3, 2025 | Medtronic MiniMed, Inc. Paradigm REF: MMT-712 and MMT-715 Open, Classified |
LZG | K053177 K120206 |
| Oct 3, 2024 | Medtronic MiniMed, Inc. MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762;
MiniMed 770G, REF: MMT-1880, MMT Open, Classified |
OZP | None listed |
| Oct 3, 2024 | Medtronic MiniMed, Inc. MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750;
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;
MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT- Open, Classified |
OYC | None listed |
| Oct 3, 2024 | Medtronic MiniMed, Inc. MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;
MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851 Open, Classified |
OZO | None listed |
| Feb 7, 2024 | Medtronic MiniMed, Inc. Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3 Open, Classified |
OZP | None listed |
| Jan 1, 2023 | Medtronic MiniMed Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system Open, Classified |
MDS | None listed |
| Nov 8, 2022 | Medtronic MiniMed Insulin Pump/Model:
MiniMed 620G/ MMT-1750
MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752 Open, Classified |
OYC | None listed |
| Nov 8, 2022 | Medtronic MiniMed Insulin Pump/Model:
MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754;
MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742 Open, Classified |
OZP | None listed |
| May 23, 2022 | Medtronic MiniMed MiniMed 780G Insulin Pump (O.U.S. Version) Open, Classified |
OZP | None listed |
| May 23, 2022 | Medtronic MiniMed MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) Open, Classified |
OZP | None listed |
Newest 50 of 99.