Cardiovascular · 510(k) · 2018
FibriCheck
Qompium nv. Cleared by FDA on 28 September 2018 under submission K173872, product code DXH (transmitters and receivers, electrocardiograph, telephone). What FDA's record says, in FDA's words.
Device record · K173872
- Device. FibriCheckDEVICE
- Company. Qompium nv (BE)COMPANY
- Decision. 28 September 2018, 510(k), substantially equivalent (traditional review); received 20 December 2017DECISION
- Panel. CardiovascularPANEL
- Product code. DXH, Transmitters And Receivers, Electrocardiograph, TelephoneCODE
- Regulation. 21 CFR 870.2920, Class IIREG
- Source. FDA database entry · decision document (9 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.
FibriCheck is indicated for self-testing by patients, who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis. Submitter: FibriCheck Qompium NV Premarket Notification:
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.
- Mentionstriage or notification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 72 reports filed against devices carrying product code DXH. 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:
17 February 2026 · Malfunction · KARDIA · ALIVECOR · report MW5183899
RECEIVED NEW ALIVECOR KARDIA 6L ELECTROCARDIOGRAPHY (ECG/EKG) DEVICE; 6-LEAD MODE DOES NOT WORK ON CUSTOMER'S ANDROID SMARTPHONE BUT 2-LEAD MODE WORKS. ON A FRIEND'S IPHONE, THAT VERSION OF THE APP WORKS IN BOTH MODES WITH THE DEVICE. ONLINE REVIEWS OF THE ANDROID APP SUGGEST THAT A RECENT UPDATE BROKE THIS BASIC FUNCTIONALITY.
12 December 2025 · Malfunction · HOMECG+ · LOHMAN TECHNOLOGIES, LLC · report 3012267350-2025-00019
THE PATIENT REPORTS THAT THE DEVICE SHUTS OFF AFTER BEING TURNED ON AND DOES NOT COMPLETE THE FULL COUNTDOWN. THE PATIENT HAS REPLACED THE BATTERIES BUT THE ISSUE PERSISTS. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
12 December 2025 · Malfunction · HOMECG+ · LOHMAN TECHNOLOGIES, LLC · report 3012267350-2025-00020
THE PATIENT REPORTS THAT THE DEVICE POWERS ON, THEN TURNS OFF AFTER A FEW SECONDS AND DOES NOT GO INTO THE FULL COUNTDOWN. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
12 December 2025 · Malfunction · HOMECG+ · LOHMAN TECHNOLOGIES, LLC · report 3012267350-2025-00017
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
12 December 2025 · Malfunction · HOMECG+ · LOHMAN TECHNOLOGIES, LLC · report 3012267350-2025-00018
THE PATIENT REPORTS THAT THE DEVICE BLINKS A BLANK SCREEN DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
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 DXH, in Cardiovascular, or cleared in 2018. 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.