Cardiovascular · 510(k) · 2025
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
Abbott. Cleared by FDA on 17 September 2025 under submission K251221, product code MXD (recorder, event, implantable cardiac, (with arrhythmia detection)). What FDA's record says, in FDA's words.
Device record · K251221
- Device. Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)DEVICE
- Company. AbbottCOMPANY
- Decision. 17 September 2025, 510(k), substantially equivalent (traditional review); received 21 April 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 (10 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.
if it is known. This K251221Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? Assert-lQ (DM5000); Assert-lQ (DM5300); Assert-lQ (DM5500); Merlin.net (MN7000) IPlease provide your Indications for Use below. The Assert-lQ TM 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 pauses. 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-lQ ICM has not been specifically tested for pediatric use. I Please select the types of uses (select one or both, as Z Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)applicable). Assert-IQ ABBOTT TRADITIONAL 510(K) ASSERT-IQ ICM SYSTEM WITH AI 1 510(k) Summary Date Prepared: April 18, 2025 Submitter: Abbott Medical Address: 15900 Valley View Ct. Sylmar, CA 91342 USA Phone: (818) 362-6822 Contact Person: Winnie Yik Laurel Jackson Assoc. Director, Regulatory […]
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 namedCT
- Mentionsa diagnostic claim
- Mentionsprescription use
- 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, 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.