Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

K230292

Samsung Electronics Co., Ltd · cleared 2023-05-02 · product code QDA · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Samsung ECG Monitor App with Irregular Heart Rhythm Notification (IHRN) Feature is a software as a medical device (SaMD) that consists of a pair of mobile medical apps: one app on a compatible Samsung wearable and the other on a compatible Samsung phone, both general-purpose computing platforms.”
AlgorithmThe IHRN feature of the subject device uses Photoplethysmograph (PPG) technology to extract rhythm information. A PPG array on the back side of the Galaxy Watch wearable device, in contact with the dorsal side of the wrist, collects data as tachograms of specific frequencies. The algorithm classifies the collected tachogram as either AFib or Sinus. Accelerometer and other sensor data also inform the algorithm to exclude tachograms from classification due to noise.
source quote (p.5)
“The IHRN feature of the subject device uses Photoplethysmograph (PPG) technology to extract rhythm information. A PPG array on the back side of the Galaxy Watch wearable device, in contact with the dorsal side of the wrist, collects data as tachograms of specific frequencies. The algorithm classifies the collected tachogram as either AFib or Sinus. Accelerometer and other sensor data also inform the algorithm to exclude tachograms from classification due to noise.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Retrospective clinical

n=810 patients

endpoints: Subject-level irregular rhythm notification accuracy, measured by sensitivity and specificity; Tachogram-level positive predictive value

Bench

sample size not stated

endpoints: covering potential confounder conditions

Bench

sample size not stated

Bench

sample size not stated

Bench

sample size not stated

endpoints: General safety tests: Electrical safety, electromagnetic compatibility, radio frequency emissions, material safety for skin contact, thermal safety for skin contact tests; Device robustness tests: Resistance to electrostatic discharge, water ingress and breakage tests

Reported performance (3 observations)

sensitivity0.68CI 95% CI:59.9%, 75.4%
source quote (p.7)
“Sensitivity - 68% (95% CI:59.9%, 75.4%)”
specificity0.988CI 95% CI:97.6%, 99.5%
source quote (p.7)
“Specificity - 98.8% (95% CI:97.6%, 99.5%)”
ppvas written: “PPV”0.957CI 95% CI: 94.7%, 96.7%
source quote (p.7)
“PPV-95.7% (95% CI: 94.7%, 96.7%)”

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

0
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
+14%
vs code's own 3-yr baseline
0
drift signals on this device

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/K230292