Medtronic Minimed
Medtronic Minimed holds FDA 510(k) medical device clearances, first cleared 1986, most recent 2026, with 33 FDA device recalls on record.
Name variants for Medtronic Minimed
as filed with FDA- Medtronic Minimed
- Medtronic MiniMed
Top product codes for Medtronic Minimed
FDA recalls by Medtronic Minimed
10 most recent of 33- Z-0776-2023 — Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- Z-0194-2023 — Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
- Z-0193-2023 — 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
- Z-1355-2022 — MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
- Z-1358-2022 — MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
- Z-1357-2022 — MiniMed 740G Insulin Pump (O.U.S. Version)
- Z-1352-2022 — MiniMed 620G Insulin Pump (O.U.S. version)
- Z-1359-2022 — MiniMed 780G Insulin Pump (O.U.S. Version)
- Z-1356-2022 — MiniMed 720G Insulin Pump (O.U.S. Version)
- Z-1353-2022 — MiniMed 630G Insulin Pump (U.S. and Canada Version)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Minimed
- K261962 — SmartGuard Technology; Predictive Low Glucose Technology
- K253701 — SmartGuard Technology; Predictive Low Glucose Technology
- K253512 — MiniMed Go App
- K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
- K241622 — Extended Reservoir; MiniMed Reservoir
- K160860 — MiniMed Quick-serter
- K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
- K100432 — POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
- K073356 — PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
- K053177 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
- K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- K052432 — MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2
- K043600 — MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
- K041317 — MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
- K041318 — MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
- K040676 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
- K040061 — MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
- K032484 — MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
- K032485 — MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
- K032164 — DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
- K032005 — MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
- K031917 — MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
- K991936 — 3.0 ML RESERVOIR, MODEL 103/193
- K993012 — MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
- K991979 — SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
- K992300 — QUICK-SERTER, MODEL 395
- K991013 — MINIMED 407C INFUSION PUMP, MODEL 407C
- K990801 — MINIMED 508 INSULIN PUMP
- K974163 — MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
- K972107 — MINIMED INFUSION PUMP, MODEL 507C
- K963948 — MINIMED INSULIN PUMP, MODEL 505
- K970479 — MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
- K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128
- K964455 — POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
- K964456 — POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
- K961474 — POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
- K960001 — MINIMED INFUSION PUMP, MODEL MMT-507
- K954969 — POLYFIN QR SUBCUTANEOUS INFUSION SET
- K942181 — SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
- K922670 — THE MINIMED MODEL 404-SP AND 504-S
- K912458 — MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
- K901588 — MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
- K895436 — MODIFIED MINIMED III INFUSION PUMP
- K890457 — MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
- K880623 — MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP
- K874564 — MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
- K864327 — MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP
- K864138 — MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
- K864517 — MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
Data sourced from openFDA. This site is unofficial and independent of the FDA.