Cardiovascular · 510(k) · 2025
Volta AF-Xplorer
Volta Medical. Cleared by FDA on 9 May 2025 under submission K243812, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K243812
- Device. Volta AF-XplorerDEVICE
- Company. Volta Medical (FR)COMPANY
- Decision. 9 May 2025, 510(k), substantially equivalent (traditional review); received 11 December 2024DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (11 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.
The Volta AF-Xplorer assists operators in the real -time manual or automatic annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra -cardiac atrial electrograms exhibiting spatiotemporal dispersion during atrial fibrillation or atrial tachycardia. Differences between subject and predicate intended use: The intended use / indications for use of the subject and predicate devices are identical with the exception that the qualifying language related to the clinical significance of the device has been removed based upon the results of the Tailored-AF clinical study which provide new clinical evidence related to the device safety, effectiveness and performance. The updated indications for use statement and additions to the product labeling do not alter the
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.
- Mentionsnone of the tracked terms matched
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, from Volta Medical, 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.