Cardiovascular · 510(k) · 2025
VitalRhythm
VitalConnect, Inc.. Cleared by FDA on 17 April 2025 under submission K242129, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K242129
- Device. VitalRhythmDEVICE
- Company. VitalConnect, Inc.COMPANY
- Decision. 17 April 2025, 510(k), substantially equivalent (traditional review); received 22 July 2024DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
VitalRhythm is a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias. VitalRhythm is compatible with the “Vista Solution” platform, which includes the VitalPatch biosensor and VistaCenter web application. VitalRhythm is intended to be used for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings for non-urgent clinical decision-making. VitalRhythm provides analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch in patients who are 18 years of age or older. Results of the VitalRhythm are displayed within the VistaCenter web application to be reviewed and confirmed by qualified healthcare professionals and/or cardiac technicians. VitalRhythm is not intended for use in life-supporting or sustaining systems or for critical care monitoring. The arrhythmia analysis results are not intended to be the sole means of diagnosis and are offered on an advisory basis only, in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,558 reports filed against devices carrying product code DQK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · QUANTIEN · Abbott Medical · report 2184149-2026-00257
During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18928
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18932
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18933
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18934
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQK, in Cardiovascular, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.