Minimed, Inc.: FDA clearances and approvals
Minimed, Inc. has 9 FDA 510(k) clearances (first 2000, latest 2003), across 6 product codes in 2 review panels. Median 510(k) review time: 63 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| LZG | Pump, Infusion, Insulin | 2 | 2 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
Most recent Minimed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031541 | PARADIGMPAL, MODEL MMT-7330 | LZG | 2003-11-18 | 186 |
| K031390 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 | LGZ | 2003-07-23 | 82 |
| K030531 | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER | LZG | 2003-06-17 | 118 |
| K021974 | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 | MRZ | 2002-08-06 | 50 |
| K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | KZH | 2001-04-05 | 56 |
| K001832 | PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 | FPA | 2000-08-18 | 63 |
| K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 | FRN | 2000-08-18 | 63 |
| K001828 | PARADIGM 1.5ML RESERVOIR, MODEL 326 | FRN | 2000-08-18 | 63 |
| K001827 | PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 | FPA | 2000-08-18 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Minimed, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Minimed, Inc.'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 FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Minimed, Inc. have?
Minimed, Inc. has 9 FDA 510(k) clearances (first 2000, latest 2003), across 6 product codes in 2 review panels.
How long does FDA take to clear Minimed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Minimed, Inc.'s cleared 510(k)s is 63 days.
What devices does Minimed, Inc. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 2); FRN (Pump, Infusion, 2); LZG (Pump, Infusion, Insulin, 2).
Has Minimed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Minimed, Inc. Related entities may recall under other names.
Next steps
- See all 9 Minimed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Minimed, Inc.'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.