MXC · Class II · 21 CFR 870.2800

FDA Product Code MXC: Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

Leading manufacturers include Abbott (St. Jude Medical), Medtronic Vascular and Abbott.

23
Total
23
Cleared
102d
Avg days
1998
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) Devices (Product Code MXC)

23 devices
1–23 of 23
Cleared May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
K230286
Abbott Medical
Cardiovascular · 104d
Cleared Aug 13, 2021
Jot Dx Insertable Cardiac Monitor
K212206
Abbott (St. Jude Medical)
Cardiovascular · 29d
Cleared Dec 01, 2020
Confirm Rx Insertable Cardiac Monitor
K202876
Abbott (St. Jude Medical)
Cardiovascular · 64d
Cleared Nov 23, 2020
Confirm Rx Insertable Cardiac Monitor
K202888
Abbott (St. Jude Medical)
Cardiovascular · 56d
Cleared Mar 17, 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310
Abbott (St. Jude Medical)
Cardiovascular · 109d
Cleared Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
K192593
Abbott
Cardiovascular · 28d
Cleared Apr 10, 2019
Confirm Rx Insertable Cardiac Monitor
K190295
Abbott (St. Jude Medical)
Cardiovascular · 58d
Cleared Mar 29, 2019
Confirm Rx Insertable Cardiac Monitor
K182981
Abbott
Cardiovascular · 151d
Cleared Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
K173232
St Jude Medical
Cardiovascular · 29d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K011098
Medtronic Vascular
Cardiovascular · 23d
Cleared Feb 14, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667
Medtronic Vascular
Cardiovascular · 78d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K994331
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 16, 1998
REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
K972242
Medtronic Vascular
Cardiovascular · 214d

About Product Code MXC - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code MXC since 1998, with 23 receiving FDA clearance (average review time: 102 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.