Sleep Apnea Feature (v2.0)
Samsung Electronics Co., Ltd. · K261011
FDA-authorized Predetermined Change Control Plan
- Company
- Samsung Electronics Co., Ltd.
- 510(k)/De Novo #
- K261011
- Decision date
- 2026-07-20
- Panel
- Anesthesiology
- Pathway
- 510(k)
- Category
- AI/SaMD
- PCCP type
- Retraining
- Monitoring commitment
- Not stated
What this PCCP covers. Permits model retraining with additional data
Other PCCPs from Samsung Electronics Co., Ltd.
Other Anesthesiology PCCPs
- K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd.2026-06-02AI/SaMDRetraining
- K254102GlucommanderGlytec, LLC2026-05-27Non-AIChange management
- K253281UpDocUpdoc, Inc.2025-12-23AI/SaMDOther
- K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp2025-12-05AI/SaMDRetraining
- K243567Tyto Insights for Rhonchi DetectionTyto Care , Ltd.2025-04-07AI/SaMDRetraining
Want the monitoring teardown?
We read the PCCP for Sleep Apnea Feature (v2.0), 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.