Cleared Traditional

K230286 - Assert-IQ™ Insertable Cardiac Monitor

K230286 is an FDA 510(k) clearance for Assert-IQ Insertable Cardiac Monitor, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code MXC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K230286

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.

MXC Device Classification - Class 2, Special Controls

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 18
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