510(k) · Cleared
Recalled · Class II · 2026LUX-Dx II (M302); LUX-Dx II+ (M312)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cleared on Aug 19, 2023 as substantially equivalent to K193473 (Boston Scientific Corporation, 2020) after a 103-day review. Its family tree reaches back 11 generations to 1987. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Aug 19, 2023
- Review
- 103 days
- Class
- Class II
- Product code
- MXD
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 11 generations to K864889 (1987). 59 ancestors in all, the oldest K832113 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 7 generations between
- 3 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 2 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- 1 generation backK193473 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile…Boston Scientific Corporation · 2020
- This deviceK231328 LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp · 2023
- Descendant · cites it directly · 0 of its ownK252593 LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable…Boston Scientific Corporation · 2025
Show all 11 generations
- Root · 11 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 10 generations backK950264 MaglifeOdam · 1996
- 9 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 8 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 7 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 6 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 5 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 4 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 3 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 2 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- 1 generation backK193473 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile…Boston Scientific Corporation · 2020
- This deviceK231328 LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp · 2023
Most influential descendants
Showing 1 of 1 · See all- K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −10 | K950264 | Maglife | Odam | 1996 | — |
| −9 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −8 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −7 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −6 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −5 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −4 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| −3 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| −2 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| −1 | K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx… | Boston Scientific Corporation | 2020 | — |
| 0 (this device) | K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023 | — |
| +1 | K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac… | Boston Scientific Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MXD device
- #1 K262735 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)score 16.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Summary page 4…I Classification Regulation: 21 CFR 870.1025 3. Predicate Device Trade Name: LUX-Dx™ Insertable Cardiac Monitor Manufacturer: Boston Scientific Corp Clearance Number: K193473, 26 June 2020 Common Name: Arrythmia detector and alarm Product Code/Panel: MXD, Cardiovascular Device Class and Panel: Class II… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2026 | Class II | Z-3082-2026 | Software design | 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… |
| Aug 6, 2026 | Class II | Z-3081-2026 | Software design | 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… |
| Aug 6, 2026 | Class II | Z-3083-2026 | Software design | 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… |
| Mar 30, 2026 | Class II | Z-2049-2026 | Under Investigation by firm | 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… |
| Mar 30, 2026 | Class II | Z-2048-2026 | Under Investigation by firm | 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… |
| Sep 6, 2024 | Class II | Z-0226-2025 | Under Investigation by firm | 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 59 ancestors have a recall of any class.
- Of its descendants, K252593 (Boston Scientific Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K193473.
How does its category compare?
All MXD devicesMXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MXD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXD
36in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXD
5so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXD
3,384in 2025
MAUDE reports naming product code MXD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 63 | 0 | 21 |
| 2017 | 4 | 52 | 0 | 37 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 1 | — | 0 | 70 |
| 2020 | 4 | 127 | 0 | 228 |
| 2021 | 4 | 57 | 0 | 694 |
| 2022 | 2 | — | 1 | 1,362 |
| 2023 | 6 | 76 | 1 | 1,766 |
| 2024 | 1 | — | 1 | 3,019 |
| 2025 | 3 | 36 | 0 | 3,384 |
| 2026 | 2 | — | 5 | — |
What is it indicated for?
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
The LUX-Dx has not been tested specifically for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231328: LUX-Dx II (M302); LUX-Dx II+ (M312).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231328
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026