VitalRhythm

K242129

VitalConnect, Inc. · cleared 2025-04-17 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“VitalRhythm is a cloud-based, arrhythmia detection software application that is compatible and intended to be used with the VitalConnect “Vista Solution” platform.”
Algorithmproprietary algorithm developed using deep learning techniques
source quote (p.6)
“The cloud-based VitalRhythm software application supports the analysis of ECG data and RR-interval using a proprietary algorithm developed using deep learning techniques.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=3,309 patients · 7 site(s)

endpoints: sensitivity; specificity; positive predictive value; negative predictive value; accuracy

Reported performance (50 observations)

sensitivityas written: “Atrial fibrillation/flutter Sensitivity”99.9
source quote (p.15)
“Atrial fibrillation/flutter 421 1512 99.9 99.9 99.8 99.9 99.9”
specificityas written: “Atrial fibrillation/flutter Specificity”99.9
source quote (p.15)
“Atrial fibrillation/flutter 421 1512 99.9 99.9 99.8 99.9 99.9”
ppvas written: “Atrial fibrillation/flutter PPV”99.8
source quote (p.15)
“Atrial fibrillation/flutter 421 1512 99.9 99.9 99.8 99.9 99.9”
npvas written: “Atrial fibrillation/flutter NPV”99.9
source quote (p.15)
“Atrial fibrillation/flutter 421 1512 99.9 99.9 99.8 99.9 99.9”
accuracyas written: “Atrial fibrillation/flutter Accuracy”99.9
source quote (p.15)
“Atrial fibrillation/flutter 421 1512 99.9 99.9 99.8 99.9 99.9”
sensitivityas written: “AV block (2nd degree, Type I and II) Sensitivity”98.7
source quote (p.15)
“AV block (2nd degree, Type I and II) 118 716 98.7 100.0 99.9 99.9 99.9”
specificityas written: “AV block (2nd degree, Type I and II) Specificity”100
source quote (p.15)
“AV block (2nd degree, Type I and II) 118 716 98.7 100.0 99.9 99.9 99.9”
ppvas written: “AV block (2nd degree, Type I and II) PPV”99.9
source quote (p.15)
“AV block (2nd degree, Type I and II) 118 716 98.7 100.0 99.9 99.9 99.9”
npvas written: “AV block (2nd degree, Type I and II) NPV”99.9
source quote (p.15)
“AV block (2nd degree, Type I and II) 118 716 98.7 100.0 99.9 99.9 99.9”
accuracyas written: “AV block (2nd degree, Type I and II) Accuracy”99.9
source quote (p.15)
“AV block (2nd degree, Type I and II) 118 716 98.7 100.0 99.9 99.9 99.9”
sensitivityas written: “Paroxysmal supraventricular tachycardia Sensitivity”98.6
source quote (p.15)
“Paroxysmal supraventricular tachycardia 689 1003 98.6 99.9 99.4 99.9 99.9”
specificityas written: “Paroxysmal supraventricular tachycardia Specificity”99.9
source quote (p.15)
“Paroxysmal supraventricular tachycardia 689 1003 98.6 99.9 99.4 99.9 99.9”
ppvas written: “Paroxysmal supraventricular tachycardia PPV”99.4
source quote (p.15)
“Paroxysmal supraventricular tachycardia 689 1003 98.6 99.9 99.4 99.9 99.9”
npvas written: “Paroxysmal supraventricular tachycardia NPV”99.9
source quote (p.15)
“Paroxysmal supraventricular tachycardia 689 1003 98.6 99.9 99.4 99.9 99.9”
accuracyas written: “Paroxysmal supraventricular tachycardia Accuracy”99.9
source quote (p.15)
“Paroxysmal supraventricular tachycardia 689 1003 98.6 99.9 99.4 99.9 99.9”
sensitivityas written: “Ventricular tachycardia/run Sensitivity”99.3
source quote (p.15)
“Ventricular tachycardia/run 610 737 99.3 99.9 99.4 99.9 99.9”
specificityas written: “Ventricular tachycardia/run Specificity”99.9
source quote (p.15)
“Ventricular tachycardia/run 610 737 99.3 99.9 99.4 99.9 99.9”
ppvas written: “Ventricular tachycardia/run PPV”99.4
source quote (p.15)
“Ventricular tachycardia/run 610 737 99.3 99.9 99.4 99.9 99.9”
npvas written: “Ventricular tachycardia/run NPV”99.9
source quote (p.15)
“Ventricular tachycardia/run 610 737 99.3 99.9 99.4 99.9 99.9”
accuracyas written: “Ventricular tachycardia/run Accuracy”99.9
source quote (p.15)
“Ventricular tachycardia/run 610 737 99.3 99.9 99.4 99.9 99.9”
sensitivityas written: “Pause Sensitivity”99.7
source quote (p.15)
“Pause 200 960 99.7 100.0 99.9 100.0 100.0”
specificityas written: “Pause Specificity”100
source quote (p.15)
“Pause 200 960 99.7 100.0 99.9 100.0 100.0”
ppvas written: “Pause PPV”99.9
source quote (p.15)
“Pause 200 960 99.7 100.0 99.9 100.0 100.0”
npvas written: “Pause NPV”100
source quote (p.15)
“Pause 200 960 99.7 100.0 99.9 100.0 100.0”
accuracyas written: “Pause Accuracy”100
source quote (p.15)
“Pause 200 960 99.7 100.0 99.9 100.0 100.0”
sensitivityas written: “Others (inconclusive) Sensitivity”98.9
source quote (p.15)
“Others (inconclusive) 1547 1923 98.9 99.9 99.2 99.9 99.9”
specificityas written: “Others (inconclusive) Specificity”99.9
source quote (p.15)
“Others (inconclusive) 1547 1923 98.9 99.9 99.2 99.9 99.9”
ppvas written: “Others (inconclusive) PPV”99.2
source quote (p.15)
“Others (inconclusive) 1547 1923 98.9 99.9 99.2 99.9 99.9”
npvas written: “Others (inconclusive) NPV”99.9
source quote (p.15)
“Others (inconclusive) 1547 1923 98.9 99.9 99.2 99.9 99.9”
accuracyas written: “Others (inconclusive) Accuracy”99.9
source quote (p.15)
“Others (inconclusive) 1547 1923 98.9 99.9 99.2 99.9 99.9”
sensitivityas written: “Sinus Sensitivity”99.8
source quote (p.15)
“Sinus 3009 5906 99.8 99.9 99.8 99.9 99.8”
specificityas written: “Sinus Specificity”99.9
source quote (p.15)
“Sinus 3009 5906 99.8 99.9 99.8 99.9 99.8”
ppvas written: “Sinus PPV”99.8
source quote (p.15)
“Sinus 3009 5906 99.8 99.9 99.8 99.9 99.8”
npvas written: “Sinus NPV”99.9
source quote (p.15)
“Sinus 3009 5906 99.8 99.9 99.8 99.9 99.8”
accuracyas written: “Sinus Accuracy”99.8
source quote (p.15)
“Sinus 3009 5906 99.8 99.9 99.8 99.9 99.8”
sensitivityas written: “Normal sinus rhythm Sensitivity”98.9
source quote (p.15)
“Normal sinus rhythm 2394 4201 98.9 99.1 99.1 98.9 99.0”
specificityas written: “Normal sinus rhythm Specificity”99.1
source quote (p.15)
“Normal sinus rhythm 2394 4201 98.9 99.1 99.1 98.9 99.0”
ppvas written: “Normal sinus rhythm PPV”99.1
source quote (p.15)
“Normal sinus rhythm 2394 4201 98.9 99.1 99.1 98.9 99.0”
npvas written: “Normal sinus rhythm NPV”98.9
source quote (p.15)
“Normal sinus rhythm 2394 4201 98.9 99.1 99.1 98.9 99.0”
accuracyas written: “Normal sinus rhythm Accuracy”99
source quote (p.15)
“Normal sinus rhythm 2394 4201 98.9 99.1 99.1 98.9 99.0”
sensitivityas written: “Sinus bradycardia Sensitivity”97
source quote (p.15)
“Sinus bradycardia 488 1009 97.0 99.8 98.9 99.6 99.5”
specificityas written: “Sinus bradycardia Specificity”99.8
source quote (p.15)
“Sinus bradycardia 488 1009 97.0 99.8 98.9 99.6 99.5”
ppvas written: “Sinus bradycardia PPV”98.9
source quote (p.15)
“Sinus bradycardia 488 1009 97.0 99.8 98.9 99.6 99.5”
npvas written: “Sinus bradycardia NPV”99.6
source quote (p.15)
“Sinus bradycardia 488 1009 97.0 99.8 98.9 99.6 99.5”
accuracyas written: “Sinus bradycardia Accuracy”99.5
source quote (p.15)
“Sinus bradycardia 488 1009 97.0 99.8 98.9 99.6 99.5”
sensitivityas written: “Sinus tachycardia Sensitivity”99.4
source quote (p.15)
“Sinus tachycardia 914 1161 99.4 99.5 97.7 99.8 99.5”
specificityas written: “Sinus tachycardia Specificity”99.5
source quote (p.15)
“Sinus tachycardia 914 1161 99.4 99.5 97.7 99.8 99.5”
ppvas written: “Sinus tachycardia PPV”97.7
source quote (p.15)
“Sinus tachycardia 914 1161 99.4 99.5 97.7 99.8 99.5”
npvas written: “Sinus tachycardia NPV”99.8
source quote (p.15)
“Sinus tachycardia 914 1161 99.4 99.5 97.7 99.8 99.5”
accuracyas written: “Sinus tachycardia Accuracy”99.5
source quote (p.15)
“Sinus tachycardia 914 1161 99.4 99.5 97.7 99.8 99.5”

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/K242129