Medtronic Minimed: FDA clearances and approvals
Medtronic Minimed has 57 FDA 510(k) clearances (first 1986, latest 2026), plus 7 PMA decisions, across 15 product codes in 2 review panels. Median 510(k) review time: 81 days. Since 2017 its median was 71 days, against 201 days for all cleared 510(k)s in the same product codes. openFDA lists 96 product recalls by a recalling firm named Medtronic Minimed. It is the industry lead sponsor of 60 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 66 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 8 |
| 2016 | 1 | 177 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 392 |
| 2023 | 0 | — |
| 2024 | 2 | 44 |
| 2025 | 2 | 110 |
| 2026 | 6 | 67 |
Review time against the same product codes
Since 2017, Medtronic Minimed's cleared 510(k)s took a median 71 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 201 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 15 | 15 |
| FRN | Pump, Infusion | 13 | 13 |
| FPA | Set, Administration, Intravascular | 12 | 12 |
| MDS | Sensor, Glucose, Invasive | 4 | 0 |
| QJI | Interoperable Automated Glycemic Controller | 4 | 4 |
| KZH | Introducer, Syringe Needle | 3 | 3 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 3 | 3 |
| FPK | Tubing, Fluid Delivery | 2 | 2 |
| NDC | Calculator, Drug Dose | 2 | 2 |
| FRW | Scale, Patient | 1 | 1 |
Plus 5 more product codes.
Review panels
- Clinical Chemistry (32)
- General Hospital (32)
Most recent Medtronic Minimed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | QJI | 2026-07-09 | 28 |
| K253743 | MiniMed Flex pump | QFG | 2026-03-12 | 108 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | QJI | 2026-02-03 | 71 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | QFG | 2026-01-15 | 97 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | QJI | 2026-01-14 | 58 |
| K253512 | MiniMed Go App | NDC | 2026-01-08 | 63 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | QJI | 2025-08-29 | 130 |
| K251032 | MiniMed 780G insulin pump | QFG | 2025-07-01 | 89 |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | NDC | 2024-11-12 | 60 |
| K241622 | Extended Reservoir; MiniMed Reservoir | LZG | 2024-07-02 | 27 |
47 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250012 | PMA | Simplera Sync Sensor, Guardian 4 Sensor | 2025-08-06 |
| P160007 | PMA | Guardian Connect system | 2018-03-08 |
| P160017 | PMA | MiniMed 670G System | 2016-09-28 |
| P150001 | PMA | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) | 2016-08-10 |
| P150029 | PMA | IPRO2 CGM SYSTEM WITH ENLITE SENSOR | 2016-06-17 |
Recalls
96 product recalls in 42 recall events; 54 initiated in the last five years. Most recent: 2026-07-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Medtronic Minimed is the industry lead sponsor of 60 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07408141: MiniMed Fit Payload Wear Study (Recruiting, started 2026-02-19)
- NCT07228117: GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes (Recruiting, started 2026-02-02)
- NCT06739811: Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347) (Recruiting, started 2025-03-21)
- NCT06645834: Smart MDI Study (CIP343) (Completed, started 2024-12-06)
- NCT06604871: Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children (Completed, started 2024-10-29)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medtronic Minimed's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Medtronic Minimed have?
Medtronic Minimed has 57 FDA 510(k) clearances (first 1986, latest 2026), plus 7 PMA decisions, across 15 product codes in 2 review panels.
How long does FDA take to clear Medtronic Minimed's 510(k)s?
The median time from FDA receipt to decision across Medtronic Minimed's cleared 510(k)s is 81 days. Since 2017: 71 days, versus 201 days for all cleared 510(k)s in the same product codes.
What devices does Medtronic Minimed make?
Its most frequent FDA product codes are LZG (Pump, Infusion, Insulin, 15); FRN (Pump, Infusion, 13); FPA (Set, Administration, Intravascular, 12).
Has Medtronic Minimed had device recalls?
openFDA lists 96 product recalls in 42 recall events by a recalling firm whose name matches Medtronic Minimed; the most recent began 2026-07-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 57 Medtronic Minimed clearances with predicates and recalls
- Run predicate analysis for product code LZG, Medtronic Minimed's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.