Diabetes Data Management System (DDMS), Model 7333
FDA 510(k) K032164 · Medtronic Minimed
510(k) numberK032164
Submission
- Device name
- Diabetes Data Management System (DDMS), Model 7333
- Applicant
- Medtronic Minimed
Northridge, CA, US - Received
- July 15, 2003
- Decision date
- October 23, 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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| 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 |
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| K261962 | SmartGuard Technology; Predictive Low Glucose TechnologyQJI · Special | 07/09/2026SE |
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| 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 Diabetes Data Management System (DDMS), Model 7333 cleared by the FDA?
Diabetes Data Management System (DDMS), Model 7333 (K032164) received a 510(k) decision of Substantially Equivalent on October 23, 2003, 100 days after the submission was received.
What is the product code of K032164?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.