SmartGuard technology; Predictive Low Glucose technology
Medtronic Minimed, Inc. · K253585
FDA-authorized Predetermined Change Control Plan
- Company
- Medtronic Minimed, Inc.
- 510(k)/De Novo #
- K253585
- Decision date
- 2026-01-14
- Panel
- Clinical Chemistry
- Pathway
- 510(k)
- Category
- AI hardware
- PCCP type
- I/O expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits input/output expansion to compatible devices
Other PCCPs from Medtronic Minimed, Inc.
- K253743MiniMed Flex pumpMedtronic Minimed, Inc.2026-03-12Non-AII/O expansion
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.2026-01-15AI hardwareI/O expansion
- K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2025-08-29AI/SaMDCompatibility expansion
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.2025-07-01Non-AICompatibility expansion
Other Clinical Chemistry PCCPs
- K253976iLet ACE PumpBeta Bionics, Inc.2026-04-30AI hardwareI/O expansion
- K253743MiniMed Flex pumpMedtronic Minimed, Inc.2026-03-12Non-AII/O expansion
- K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed2026-02-03AI hardwareI/O expansion
- K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.2026-01-15AI hardwareI/O expansion
- K251152DBLG2Diabeloop2025-12-19AI/SaMDUnknown
- K252357Glucose2Abbott Ireland2025-10-24Non-AICompatibility expansion
Want the monitoring teardown?
We read the PCCP for SmartGuard technology; Predictive Low Glucose technology, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.