Minimed Insulin Pump, Model 505
FDA 510(k) K963948 · Medtronic Minimed
510(k) numberK963948
Submission
- Device name
- Minimed Insulin Pump, Model 505
- Applicant
- Medtronic Minimed
Sylmar, CA, US - Received
- October 2, 1996
- Decision date
- April 8, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
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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| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| 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
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|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Special | 07/09/2026SE |
| K253743 | MiniMed Flex pumpQFG · Traditional | 03/12/2026SE |
| K253701 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Traditional | 02/03/2026SE |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFG · Traditional | 01/15/2026SE |
| K253585 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | 01/14/2026SE |
| K253512 | MiniMed Go AppNDC · Traditional | 01/08/2026SE |
| K251217 | SmartGuard technology; Predictive Low Glucose technologyQJI · Traditional | 08/29/2025SE |
| K251032 | MiniMed 780G insulin pumpQFG · Traditional | 07/01/2025SE |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional | 11/12/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | 07/02/2024SE |
Questions and answers
When was Minimed Insulin Pump, Model 505 cleared by the FDA?
Minimed Insulin Pump, Model 505 (K963948) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on April 8, 1997, 188 days after the submission was received.
What is the product code of K963948?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.