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FDA 510(k)

Withings BeamO (SCT02)

K-Number: K252474 · 2025-11-10

ApplicantWithings
Decision Date2025-11-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Withings BeamO (SCT02) is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252474. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Withings BeamO (SCT02)?

Withings BeamO (SCT02) is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Withings. The 510(k) number is K252474.

When did Withings BeamO (SCT02) receive FDA 510(k) clearance?

Withings BeamO (SCT02) received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252474.

Who is the listed applicant for Withings BeamO (SCT02)?

The FDA 510(k) record lists Withings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Withings BeamO (SCT02)?

The FDA product code for Withings BeamO (SCT02) is DPS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06637878SCT02 Clinical Accuracy ValidationCOMPLETEDNCT07595016Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-EclampsiaRECRUITINGNCT07631715Withings Hypertension Notification Retrospective StudyACTIVE_NOT_RECRUITINGNCT07654491Withings HFRN Retrospective StudyNOT_YET_RECRUITING

Other records listing Withings as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240795Withings ECG AppK231667Withings Sleep RxK230812Withings Scan Monitor 2.0K201456Scan MonitorK160544Withings Thermo (Model SCT01)

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.K243305Masimo W1Masimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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