# Medtronic Minimed

- Location (FDA's records): Northridge, CA
- FDA decisions: 64 (1986–2026): 57 510(k) clearances and 7 original PMA approvals
- Names in FDA's records: Medtronic Minimed (53); Medtronic Minimed, Inc. (10); Medtronic MiniMed (1)
- Product codes: LZG (15), FRN (13), FPA (12), MDS (4), QJI (4), QFG (3), KZH (3), NDC (2), FPK (2), OZO (1), PJT (1), MRZ (1)
- 510(k) review time since 2016: median 71 days, against 65 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 29 (19 its own); citations of its devices by later devices: 44 (19 its own)
- Recalls linked to its devices: 65 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tandem Diabetes Care, Inc.: 2 (https://510kreport.com/company/tandem-diabetes-care)
- Pacesetter Systems: 2 (https://510kreport.com/company/pacesetter-systems)
- Owen Mumford USA, Inc.: 1 (https://510kreport.com/company/owen-mumford-usa)
- Maersk Medical A/S: 1 (https://510kreport.com/company/maersk-medical-a-s)
- P/L Biomedical: 1 (https://510kreport.com/company/p-l-biomedical)
- Minimed, Inc.: 1 (https://510kreport.com/company/minimed)
- Companion Medical, Inc.: 1 (https://510kreport.com/company/companion-medical)

## Firms that cite its devices most
- Deltec, Inc.: 3 (https://510kreport.com/company/deltec)
- Collaborativemed, LLC: 2 (https://510kreport.com/company/collaborativemed)
- Disetronic Medical Systems: 2 (https://510kreport.com/company/disetronic-medical-systems)
- Sterling Medivations, Inc.: 2 (https://510kreport.com/company/sterling-medivations)
- Applied Diabetes Research, Incorporated: 2 (https://510kreport.com/company/applied-diabetes-research)
- Tandem Diabetes Care, Inc.: 2 (https://510kreport.com/company/tandem-diabetes-care)
- Nilimedix, Ltd.: 1 (https://510kreport.com/company/nilimedix)
- Sooil Development Co., Ltd.: 1 (https://510kreport.com/company/sooil-development)

## Its most-cited devices
- K990801: Minimed 508 Insulin Pump (1999), cited by 4
- K991936: 3.0 ML Reservoir, Model 103/193 (2000), cited by 4
- K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133 (1996), cited by 3
- K992300: Quick-Serter, Model 395 (1999), cited by 3
- K242775: InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (2024), cited by 3
- K251032: MiniMed 780G insulin pump (2025), cited by 3

## Recent decisions
- K261962: SmartGuard Technology; Predictive Low Glucose Technology (Jul 9, 2026)
- K253743: MiniMed Flex pump (Mar 12, 2026)
- K253701: SmartGuard Technology; Predictive Low Glucose Technology (Feb 3, 2026)
- K253470: MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (Jan 15, 2026)
- K253585: SmartGuard technology; Predictive Low Glucose technology (Jan 14, 2026)
- K253512: MiniMed Go App (Jan 8, 2026)
- K251217: SmartGuard technology; Predictive Low Glucose technology (Aug 29, 2025)
- P250012: Simplera Sync Sensor, Guardian 4 Sensor (Aug 6, 2025)

Source page: https://510kreport.com/company/medtronic-minimed