Atlas FDA

MEDTRONIC MINIMED PARADIGM INSULIN PUMPS

FDA 510(k) clearance K120206 · decided 2012-03-29

Clearance details

K-number
K120206
Device name
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
2012-01-23
Decision date
2012-03-29
Days to decision
66 days
Clearance type
Special
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Northridge, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Paradigm Insulin Pump (MMT-712, MMT-715) recall (Z-1748-2026)Medtronic MiniMed, Inc.2026-04-02
Paradigm REF: MMT-712 and MMT-715 recall (Z-1255-2025)Medtronic MiniMed, Inc.2025-03-03
MiniMed Paradigm 512 Insulin pump recall (Z-1583-2020)Medtronic MiniMed2020-03-26
MiniMed Paradigm Insulin pump, model number MMT-712 recall (Z-1584-2020)Medtronic MiniMed2020-03-26
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 recall (Z-1586-2020)Medtronic MiniMed2020-03-26
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use wi recall (Z-0178-2020)Medtronic Inc.2019-11-04

PMA approvals by this applicant

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Simplera system (P160007/S060)Medtronic Minimed2026-06-12
Simplera and Simplera Sync (P160007/S062)Medtronic Minimed2026-05-26
MiniMed Go app; Simplera sensor (P160007/S058)Medtronic Minimed2026-01-23
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Simplera System (P160007/S057)Medtronic Minimed2025-12-05
Medtronic MiniMed 630G System (P150001/S110)Medtronic Minimed2025-10-16