510(k) Report

FDA applicant

Minimed, Inc.

Northridge, CA9 decisions2000–20037 recalls

FDA records 9 decisions for Minimed, Inc. (Northridge, CA) from 2000 to 2003: 9 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LZG (Pump, Infusion, Insulin). 7 recalls are linked to its devices, 1 Class I.

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 Minimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Minimed, Inc. since 2007.

Recalls per year

1in 2026

2007: 12013: 12018: 1, 1 Class I2026 (partial year): 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • LZGPump, Infusion, Insulin2decisions
  • FRNPump, Infusion2decisions
  • MRZAccessories, Pump, Infusion1decision
  • LGZWarmer, Thermal, Infusion Fluid1decision
  • KZHIntroducer, Syringe Needle1decision

Who builds on its devices?

Later devices cite its devices 6 times; 0 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.

  • K030531Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterMinimed, Inc. · 20032cite it
  • K010377Mimimed Sil-Serter Infusion Set Insertion System, Model 385Minimed, Inc. · 20012cite it
  • K031390Medtronic Minimed Paradigm Insulin Pump, Model MMT-712Minimed, Inc. · 20031cites it
  • K001828Paradigm 1.5ML Reservoir, Model 326Minimed, Inc. · 20001cites it

What has FDA decided for it lately?

  • K031541Paradigmpal, Model MMT-7330Minimed, Inc. · 2003
  • K031390Medtronic Minimed Paradigm Insulin Pump, Model MMT-712Minimed, Inc. · 20032 recalls
  • K030531Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterMinimed, Inc. · 20033 recalls
  • K021974Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311Minimed, Inc. · 2002
  • K010377Mimimed Sil-Serter Infusion Set Insertion System, Model 385Minimed, Inc. · 2001
  • K001832Paradigm Sof-Set Ultimate QR, Models 317 and 318Minimed, Inc. · 2000
  • K001827Paradigm Sof-Set Micro QR, Models 324 and 325Minimed, Inc. · 2000
  • K001829Minimed Paradigm Insulin Pump, Model 511Minimed, Inc. · 20001 Class I recall

All 9 as Minimed, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K120206Paradigm Insulin Pump (MMT-712, MMT-715)Feb 13, 2026Class II
  • K120206Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use…Aug 7, 2018Class I
  • K001828Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL)…Jul 3, 2013Class II
  • K001829Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models…Apr 27, 2007
  • K030531Medtronic MiniMed Paradigm Model 712Sep 14, 2004
  • K022580BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027…Jan 29, 2004