510(k) · Cleared
ClearedDARI Health
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientific Analytics, Inc. · LXJ Interactive Rehabilitation Exercise Devices
Cleared on Mar 7, 2019 as substantially equivalent to K030714 (Peak Performance Technologies, Inc., 2003) after a 338-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Mar 7, 2019
- Review
- 338 days
- Class
- Class II
- Product code
- LXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K890076 (1989). No later device cites it as a predicate yet.
- 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 deviceK180880 DARI HealthScientific Analytics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K030714 | Peak MotusSummary page 5…hysical Medicine 5. Legally Marketed Predicate Devices: a. Peak Motus Motion Measurement System i. 510(k) Owner: Peak Performance Technologies, Inc. i. 510(k) Number: K030714 iii. 21 C.F.R. § 890.5360 (Class II) iv. Product Code: LXJ bt 6. Device Description DART’s existing motion capture technolog… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
- 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. 2019, 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?
DARI Health is a computer and video system used to quantify and graphically display human movement patterns and techniques for uses such as assessment and training of limb or body motion in pre/post rehabilitation evaluation, physical therapy, and the like.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180880: DARI Health.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180880
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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