MEDTRONIC MINIMED PARADIGM INSULIN PUMPS— 510(k) K120206
Substantially EquivalentMedtronic Minimed
FDA 510(k) clearance K120206 for MEDTRONIC MINIMED PARADIGM INSULIN PUMPS, Substantially Equivalent on 2012-03-29. Applicant: Medtronic Minimed. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Northridge, CA, US
Recent devices under product code LZG
view allMore clearances from Medtronic Minimed
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K120206
K-number listed on FDA's recall record- Z-1748-2026 — Paradigm Insulin Pump (MMT-712, MMT-715)
- Z-1255-2025 — Paradigm REF: MMT-712 and MMT-715
- Z-1583-2020 — MiniMed Paradigm 512 Insulin pump
- Z-1584-2020 — MiniMed Paradigm Insulin pump, model number MMT-712
- Z-1586-2020 — Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
- Z-0178-2020 — Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120206.
Data sourced from openFDA. This site is unofficial and independent of the FDA.