Withings Scan Monitor 2.0

K230812

Withings · cleared 2023-08-23 · product code DPS · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-II and lead-III of a two-channel electrocardiogram (ECG).”
AlgorithmMachine Learning algorithm
source quote (p.10)
“Three distinct sets of data were used to design the algorithm. Each dataset is used in one of the usual three stages of a robust Machine Learning algorithm development: training, testing, and validation of the final (“locked") algorithm.”
Adaptive (vs locked)No
source quote (p.10)
“Each dataset is used in one of the usual three stages of a robust Machine Learning algorithm development: training, testing, and validation of the final (“locked") algorithm.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: IEC 60601-1:2005, ANSI AAMI ES60601-1:2005/A2:2021, IEC 60601-1-2:2014, IEC 60601-2-47:2012, IEC 60601-1-11, ANSI/AAMI EC57, AAMI TIR69:2017/(R2020), ANSI IEEE C63.27-2017, FCC testing per part 15

Standalone

n=2 other

Retrospective clinical

n=274 patients

endpoints: validate a rhythm classification algorithm ECG-SW1 running on the subject device Withings Scan Monitor 2.0 (WBSSM2) and its ability to detect and classify heart rhythms into one of four categories (sinus rhythm (SR), atrial fibrillation (AF), inconclusive or noise); validate the Withings Scan Monitor 2.0 (WBSSM2) ability to generate a 6-lead electrocardiogram (ECG) that is clinically equivalent to a standard 12-lead ECG

Reported performance (6 observations)

sensitivity0.99CI [0.93, 1.0]
source quote (p.12)
“Of the remaining signals (at rest + after effort), excluding other arrhythmias, Withings Scan Monitor 2.0 (WBSSM2) reached a sensitivity of 0.99 with a 95% confidence interval of [0.93, 1.0]”
specificity0.99CI [0.97, 1.0]
source quote (p.12)
“and a specificity of 0.99 with a 95% confidence interval of [0.97, 1.0].”
accuracyas written: “Accuracy (P-waves, QRS complexes and T-waves)”0.992
source quote (p.12)
“Withings Scan Monitor 2.0 (WBSSM2) accuracies computed on the visibility of all ECG waves (P-waves, QRS complexes and T-waves) was above 0.992.”
accuracyas written: “Polarity accuracy (P-waves)”0.986
source quote (p.12)
“Polarity accuracy was 0.986 for P-waves, 0.948 for QRS complex, and 0.911 for T-waves.”
accuracyas written: “Polarity accuracy (QRS complex)”0.948
source quote (p.12)
“Polarity accuracy was 0.986 for P-waves, 0.948 for QRS complex, and 0.911 for T-waves.”
accuracyas written: “Polarity accuracy (T-waves)”0.911
source quote (p.12)
“Polarity accuracy was 0.986 for P-waves, 0.948 for QRS complex, and 0.911 for T-waves.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

9
recalls in product code, 24mo
72
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
3
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Braemar Manufacturing, LLC, initiated 2024-12-18): "Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95837

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Schiller, Ag Altgasse 68 Baar Switzerland, initiated 2024-07-24): "Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95074

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230812