LUX-Dx II (M302); LUX-Dx II+ (M312)

510(k) K231328

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK231328	Date19 Aug 2023Cleared	StatusActive

6 recalls · 6 ongoing · FDA

3 recalls, same reason
- Ongoing Z-3081-2026 FDA Class II initiated 6 Aug 2026
- Ongoing Z-3083-2026 FDA Class II initiated 6 Aug 2026
- Ongoing Z-3082-2026 FDA Class II initiated 6 Aug 2026
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
2 recalls, same reason
- Ongoing Z-2048-2026 FDA Class II initiated 30 Mar 2026
- Ongoing Z-2049-2026 FDA Class II initiated 30 Mar 2026
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- Ongoing Z-0226-2025 FDA Class II initiated 6 Sep 2024
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.

1 jurisdiction

United States — FDA 510(k) Active

510(k)