510(k) · Cleared
ClearedClearEdge Balance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quadrant Biosciences · LXV Apparatus, Vestibular Analysis
Cleared on Oct 22, 2019 as substantially equivalent to K121590 (Capacity Sports, LLC, 2012) after a 299-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Oct 22, 2019
- Review
- 299 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911795 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK911795 Kinesthetic Ability Trainer (K.a.T., Model 1000)Breg, Inc. · 1991
- 2 generations backK070676 Korebalance (Kinesthetic Ability Trainer)Sportkat, LLC · 2007
- 1 generation backK121590 Vestibular Analysis ApparatusCapacity Sports, LLC · 2012
- This deviceK183661 ClearEdge Balance SystemQuadrant Biosciences · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911795 | Kinesthetic Ability Trainer (K.a.T., Model 1000) | Breg, Inc. | 1991 | — |
| −2 | K070676 | Korebalance (Kinesthetic Ability Trainer) | Sportkat, LLC | 2007 | — |
| −1 | K121590 | Vestibular Analysis Apparatus | Capacity Sports, LLC | 2012 | — |
| 0 (this device) | K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019 | — |
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 LXV? 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 LXV device
- #1 K220231 GyroStimscore 3.8 · 3 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.
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 28 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K121590.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LXV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LXV
Too few LXV 510(k)s in any year since 2007 to give a median.
Recalls per year · LXV
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXV
1in 2010
MAUDE reports naming product code LXV, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183661: ClearEdge Balance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183661
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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