SafeBeat Rx App

K251218

SafeBeat Rx, Inc. · cleared 2026-02-06 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The SafeBeat Rx App is a Software as a Medical Device (SaMD)”
AlgorithmML-based provisional ECG interval measurements; machine learning-based algorithm
source quote (p.5)
“The SafeBeat Rx App is a Software as a Medical Device (SaMD) that provides: (1) ML-based provisional ECG interval measurements of third-party ECG signals (e.g., HR, RR-interval variability, QT/QTc interval and QRS interval); and (2) optional non-device functions, including suggested antiarrhythmic drug (AAD) dosing consistent with manufacturer drug label for amiodarone, dofetilide, flecainide, sotalol and IV sotalol. The device analyzes ECG signals acquired by other ECG acquisition and storage devices. The device is only intended for traditional “wet” electrode inputs. The SafeBeat app does not directly acquire ECG data from patients. ECG data is obtained programmatically through an application programming interface (API) with the ECG acquisition and storage device, or manually via data upload through a secure web interface. The device is solely intended to analyze raw digital ECG data and does not allow the analysis of ECG signals imported by images. Provisional ECG analysis is performed by the device. The device includes both beat-level feature identification and interval estimation. The beat-level parameters are: • R-peak • QRS onset • ST onset • T-wave offset The interval estimation parameters: • Heart rate • RR interval variability • QRS duration • QT interval • QT interval variability • Heart rate corrected QT (e.g., QTcF) • Heart rate corrected QT variability”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: verification of all design input requirements and product specifications; integration testing; software validation testing; human factors usability testing

standards: AAMI ANSI IEC 62304, IEC 60601-2-25, IEC 60601-2-47, IEC 62366-1

Retrospective clinical

sample size not stated

endpoints: measure QT, QRS, and HR/RR; QTc Measurement Validation; QRS Measurement Validation; HR and R-R Peak Measurement Validation; Edge Case Testing; Arrhythmia Detection Validation: Evaluating beat-segment detection/QRS sensitivity and positive predictive value; Arrhythmia Detection Validation: Evaluating heart rate (HR) and R-R peak

standards: IEC 60601-2-25, IEC 60601-2-47

Reported performance (1 observation)

ppvas written: “positive predictive value”stated without value
source quote (p.15)
“Arrhythmia Detection Validation: Evaluating beat-segment detection/QRS sensitivity and positive predictive value against test datasets referenced in IEC 60601-2-47.”

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

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

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/K251218