Cleared Traditional

Confirm Rx Insertable Cardiac Monitor (K202888) - FDA 510(k) Clearance

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

K202888 · Abbott (St. Jude Medical) · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2020
Decision
56d
Days
Class 2
Risk

K202888 is an FDA 510(k) clearance for the Confirm Rx Insertable Cardiac Monitor. Classified as Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (product code MXC), Class II - Special Controls.

Submitted by Abbott (St. Jude Medical) (Sylmar, US). The FDA issued a Cleared decision on November 23, 2020 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott (St. Jude Medical) devices

Submission Details

510(k) Number K202888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date November 23, 2020
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 12
Devices cleared under the same product code (MXC) and FDA review panel - the closest regulatory comparables to K202888.
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Confirm Rx Insertable Cardiac Monitor
K192593 · Abbott · Oct 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · Abbott (St. Jude Medical) · Apr 2019