Cleared Traditional

Assert-IQ™ Insertable Cardiac Monitor (K230286) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230286 · Abbott Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2023
Decision
104d
Days
Class 2
Risk

K230286 is an FDA 510(k) clearance for the Assert-IQ™ Insertable Cardiac Monitor. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on May 17, 2023 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical devices

Submission Details

510(k) Number K230286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2023
Decision Date May 17, 2023
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MXC Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

All 22
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K230286.
Jot Dx Insertable Cardiac Monitor
K212206 · Abbott (St. Jude Medical) · Aug 2021
Confirm Rx Insertable Cardiac Monitor
K202876 · Abbott (St. Jude Medical) · Dec 2020
Confirm Rx Insertable Cardiac Monitor
K202888 · Abbott (St. Jude Medical) · Nov 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · Abbott (St. Jude Medical) · Mar 2020
Confirm Rx Insertable Cardiac Monitor
K192593 · Abbott · Oct 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · Abbott (St. Jude Medical) · Apr 2019