510(k) · Cleared
ClearedSmart (Smart-D, Smart-DX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bts S.P.A. · LXJ Interactive Rehabilitation Exercise Devices
Cleared on Apr 17, 2014 as substantially equivalent to K030714 (Peak Performance Technologies, Inc., 2003) and 1 other predicate after a 315-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Apr 17, 2014
- Review
- 315 days
- Class
- Class II
- Product code
- LXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890076 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK890076 OrthotrakMotion Analysis Corp. · 1989
- 2 generations backK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
- 1 generation backK030714 Peak MotusPeak Performance Technologies, Inc. · 2003
- This deviceK131660 Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014
- Descendant · cites it directly · 0 of its ownK171547 Qualisys Clinical SystemQualisys AB · 2018
Most influential descendants
Showing 1 of 1 · See all- K171547Qualisys Clinical SystemQualisys AB · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890076 | Orthotrak | Motion Analysis Corp. | 1989 | — |
| −2 | K982425 | Coda MPX30 Motion Analysis System | Pinsco Inc. Dba B & L Engineering | 1998 | — |
| −1 | K030714 | Peak Motus | Peak Performance Technologies, Inc. | 2003 | — |
| 0 (this device) | K131660 | Smart (Smart-D, Smart-DX) | Bts S.P.A. | 2014 | — |
| +1 | K171547 | Qualisys Clinical System | Qualisys AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 LXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K030714 | Peak MotusSummary page 2…510(K) Holder 510(k) No. Date Cleared PEAK MOTUS PEAK PERFORMANCE K030714 16 May 2003 TECHNOLOGIES, INC CODA CX1 MOTION… | 2003 |
| * | K033514 | Coda CX1 Motion Analysis SystemSummary page 2…16 May 2003 TECHNOLOGIES, INC CODA CX1 MOTION CHARNWOOD DYNAMICS K033514 6 Jan 2004 ANALYSIS SYSTEM LTD. _ _______… | 2004 |
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 |
|---|---|---|---|
| K171547 | Qualisys Clinical System | 2018 | 0 |
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 25 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171547 (Qualisys AB, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030714.
How does its category compare?
All LXJ devicesLXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LXJ
3in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXJ
224in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXJ
No recall names LXJ since 2007.
Adverse event reports per year · LXJ
1in 2018
MAUDE reports naming product code LXJ, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 182 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 231 | 0 | 1 |
| 2019 | 3 | 224 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131660: Smart (Smart-D, Smart-DX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131660
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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