Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter
FDA 510(k) K030531 · Minimed, Inc.
510(k) numberK030531
Submission
- Device name
- Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter
- Applicant
- Minimed, Inc.
Northridge, CA, US - Received
- February 19, 2003
- Decision date
- June 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K031541 | Paradigmpal, Model MMT-7330LZG · Traditional | 11/18/2003SE |
| K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712LGZ · Traditional | 07/23/2003SE |
| K021974 | Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311MRZ · Traditional | 08/06/2002SE |
| K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385KZH · Traditional | 04/05/2001SE |
| K001832 | Paradigm Sof-Set Ultimate QR, Models 317 and 318FPA · Traditional | 08/18/2000SE |
| K001829 | Minimed Paradigm Insulin Pump, Model 511FRN · Traditional | 08/18/2000SE |
| K001828 | Paradigm 1.5ML Reservoir, Model 326FRN · Traditional | 08/18/2000SE |
| K001827 | Paradigm Sof-Set Micro QR, Models 324 and 325FPA · Traditional | 08/18/2000SE |
Questions and answers
When was Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter cleared by the FDA?
Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter (K030531) received a 510(k) decision of Substantially Equivalent on June 17, 2003, 118 days after the submission was received.
What is the product code of K030531?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.