510(k) Report

FDA applicant

Medtronic Minimed

Northridge, CA64 decisions1986–202665 recalls

FDA records 64 decisions for Medtronic Minimed (Northridge, CA) from 1986 to 2026: 57 510(k) clearances and 7 original PMA approvals. Most are in product codes LZG (Pump, Infusion, Insulin) and FRN (Pump, Infusion). Since 2016 its 510(k)s took a median of 71 days from receipt to decision, against 65 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 19 of them its own earlier devices. 65 recalls are linked to its devices, 6 Class I.

FDA’s records also spell it “Medtronic Minimed, Inc.”, “Medtronic MiniMed”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medtronic Minimed’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 12008: 12010: 12012: 12015: 22016: 42018: 12022: 12024: 22025: 32026 (partial year): 6
2007high 6 (2026) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

15in 2026

2007: 12013: 12014: 22015: 12017: 52018: 4, 2 Class I2019: 17, 2 Class I2020: 32021: 12022: 22024: 2, 2 Class I2025: 112026 (partial year): 15
2007high 17 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Minimed by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Minimed’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZGPump, Infusion, Insulin15decisions
  • FRNPump, Infusion13decisions
  • FPASet, Administration, Intravascular12decisions
  • MDSSensor, Glucose, Invasive4decisions
  • QJIInteroperable Automated Glycemic Controller4decisions
  • QFGAlternate Controller Enabled Insulin Infusion Pump3decisions

Also: KZH (3), NDC (2), FPK (2), OZO (1), PJT (1), MRZ (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 71 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 65 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K990801Minimed 508 Insulin PumpMedtronic Minimed · 19994cite it
  • K9919363.0 ML Reservoir, Model 103/193Medtronic Minimed · 20004cite it
  • K961474Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 19963cite it
  • K992300Quick-Serter, Model 395Medtronic Minimed · 19993cite it
  • K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))Medtronic Minimed · 20243cite it
  • K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc. · 20253cite it

What has FDA decided for it lately?

  • K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
  • K253743MiniMed Flex pumpMedtronic Minimed, Inc. · 20261 recall
  • K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026
  • K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc. · 2026
  • K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2026
  • K253512MiniMed Go AppMedtronic Minimed · 20262 recalls
  • K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc. · 2025
  • P250012Simplera Sync Sensor, Guardian 4 SensorMedtronic Minimed, Inc. · 2025

All 53 as Medtronic Minimed →All 10 as Medtronic Minimed, Inc. →The one decision as Medtronic MiniMed →

What has been recalled?

65 recalls linked to its devices; the latest:

  • K253512Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600…Sep 2, 2026Class II
  • K253743Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers…Aug 20, 2026Class II
  • K251032MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;Jul 13, 2026Class II
  • P160017MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Jul 13, 2026Class II
  • K251032MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWJul 13, 2026Class II
  • K253512MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)Jun 16, 2026Class II