Cardiovascular · 510(k) · 2025
Assert-IQ (DM5100)
Abbott Medical. Cleared by FDA on 18 December 2025 under submission K253516, product code MXD (recorder, event, implantable cardiac, (with arrhythmia detection)). What FDA's record says, in FDA's words.
Device record · K253516
- Device. Assert-IQ (DM5100)DEVICE
- Company. Abbott MedicalCOMPANY
- Decision. 18 December 2025, 510(k), substantially equivalent (special review); received 12 November 2025DECISION
- Panel. CardiovascularPANEL
- Product code. MXD, Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)CODE
- Regulation. 21 CFR 870.1025, Class IIREG
- Source. FDA database entry · decision document (8 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.
for the Assert-IQ Insertable Cardiac Monitor (ICM) system as a result of this submission. The Indications for Use are provided below: The Assert-IQ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pause. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use. of 4 Assert-IQ Insertable Cardiac Monitor (ICM) System Assert-IQ 4 ICM, model DM5100 Special 510(k) Premarket Notification Product Description The Assert-IQ ICM system is intended to help physicians monitor, diagnose, and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated. The Assert-IQ Insertable Cardiac Monitor (ICM ) family of Insertable Cardiac Monitor devices includes cleared models DM5000, DM5300, and DM5500. A fourth model is being included as the subject device within this 510(k)—the A ssert-IQ 4 ICM , model DM5100. Overview of Technological features […]
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
- Mentionsa diagnostic claim
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 13,169 reports filed against devices carrying product code MXD. 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 · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07287
It was reported that the Implantable Cardiac Monitor (ICM) detected fast tachycardia episodes (FVT) due to noise. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07288
It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing Premature Ventricular Contractions (PVC)'s. It was further reported that the remote monitoring report displayed ?? marks under Current Counters and Reason For Monitoring. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07290
It was reported that the Implantable Cardiac Monitor (ICM) experienced undersensing. It was further reported that the Remote Monitoring Report displayed ?? marks under Current Counters. The ICM remains in use. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07291
It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 29 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. The ICM remains in the patient. No patient complications have been reported as a result of this event.
30 September 2026 · Malfunction · LINQ II¿ Insertable Cardiac Monitor · Medtronic Singapore Operations · report 3008973940-2026-07292
It was reported that the Implantable Cardiac Monitor (ICM) displayed early Recommended Replacement Time (RRT) having been implanted approximately 27 months. It was noted that the ICM did not meet the minimum expected longevity when accounting for device usage. The ICM remains in the patient. No patient complications have been reported as a result of this event.
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 MXD, in Cardiovascular, from Abbott 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.