Skip to content

SJM Confirm

by St Jude Medical

510(k) K122161

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122161 Date28 Nov 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MXC
Device class
Class II
Regulation
21 CFR Part 870.2800
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SJM Confirm is an implantable cardiac monitor without arrhythmia detection. It is designed to record cardiac events for monitoring purposes. This device is part of the Confirm product line and is used for cardiac event monitoring.

The SJM Confirm is supplied as a single-use device and requires follow-up visits for monitoring. It is regulated under FDA 510(k) clearance with product code MXC. The device is manufactured by St Jude Medical and is intended for cardiovascular use.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SJM Confirm used for?

    The SJM Confirm is an implantable cardiac monitor designed to record cardiac events for monitoring purposes. It does not have arrhythmia detection capabilities and is part of the Confirm product line for cardiovascular use.

  • Is the SJM Confirm a single-use device?

    Yes, the SJM Confirm is supplied as a single-use device and requires follow-up visits for monitoring. It is not designed for reuse and should be replaced after its intended use period.

  • What is the regulatory status of the SJM Confirm?

    The SJM Confirm is regulated under FDA 510(k) clearance with product code MXC. It received traditional clearance on November 28, 2012, and is classified as a Class II device for cardiovascular use.

  • How is the SJM Confirm supplied?

    The SJM Confirm is supplied as a single-use device that requires follow-up visits for monitoring. It is manufactured by St Jude Medical and is intended for cardiovascular use, with specific model information available through the manufacturer.