510(k) · Cleared
ClearedLUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cleared on Jun 26, 2020 as substantially equivalent to K132649 (Medtronic, Inc., 2014) after a 193-day review. Its family tree reaches back 10 generations to 1987. 3 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- MXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K864889 (1987). 58 ancestors in all, the oldest K832113 (1983). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 6 generations between
- 3 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 2 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 1 generation backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- This deviceK193473 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile…Boston Scientific Corporation · 2020
- Descendant · cites it directly · 1 of its ownK231328 LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK252593 LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable…Boston Scientific Corporation · 2025
- Descendant · cites it directly · 0 of its ownK210608 LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation · 2021
Show all 10 generations
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 9 generations backK950264 MaglifeOdam · 1996
- 8 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 7 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 6 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 5 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 4 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 3 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 2 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 1 generation backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- This deviceK193473 LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile…Boston Scientific Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp · 2023 · cites it directly1descendant
- K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation · 2025 · 2 generations on0descendants
- K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −9 | K950264 | Maglife | Odam | 1996 | — |
| −8 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −7 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −6 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −5 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −4 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −3 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| −2 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| −1 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| 0 (this device) | K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx… | Boston Scientific Corporation | 2020 | — |
| +1 | K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023 | 6 |
| +2 | K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac… | Boston Scientific Corporation | 2025 | — |
| +1 | K210608 | LUX-Dx Insertable Cardiac Monitor | Boston Scientific Corporation | 2021 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K132649 | Reveal Linq Insertable Cardiac MonitorSummary page 4…II Classification Regulation: 21 CFR 870.1025 3. Predicate Device Trade Name: Reveal LINQ Insertable Cardiac Monitor Manufacturer: Medtronic Inc Clearance Number: K132649, 14 February 2014 Common Name: Arrythmia detector and alarm Product Code/Panel: DSI, Cardiovascular Device Class and Panel: Cl… | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 58 ancestors have a recall of any class.
- Of its descendants, K231328 (Boston Scientific Corp, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132649.
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. 2020, 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 ECG (S-ECG) for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition, are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a heart condition 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/K193473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193473: LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193473
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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