Control-IQ+ technology
Tandem Diabetes Care, Inc. · K250798
FDA-authorized Predetermined Change Control Plan
- Company
- Tandem Diabetes Care, Inc.
- 510(k)/De Novo #
- K250798
- Decision date
- 2025-05-21
- Panel
- Clinical Chemistry
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- Compatibility expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits compatibility expansion to additional hardware
Other Clinical Chemistry PCCPs
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- 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
- K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2026-01-14AI hardwareI/O expansion
- K251152DBLG2Diabeloop2025-12-19AI/SaMDUnknown
Want the monitoring teardown?
We read the PCCP for Control-IQ+ 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.