510(k) · Cleared
ClearedVestibular Analysis Apparatus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capacity Sports, LLC · LXV Apparatus, Vestibular Analysis
Cleared on Sep 20, 2012 as substantially equivalent to K070676 (Sportkat, LLC, 2007) after a 112-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 112 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911795 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK911795 Kinesthetic Ability Trainer (K.a.T., Model 1000)Breg, Inc. · 1991
- 1 generation backK070676 Korebalance (Kinesthetic Ability Trainer)Sportkat, LLC · 2007
- This deviceK121590 Vestibular Analysis ApparatusCapacity Sports, LLC · 2012
- Descendant · cites it directly · 0 of its ownK183661 ClearEdge Balance SystemQuadrant Biosciences · 2019
- Descendant · cites it directly · 0 of its ownK190735 EQ BalanceUpright Science, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK173669 K-D BalanceKing-Devick Technologies, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911795 | Kinesthetic Ability Trainer (K.a.T., Model 1000) | Breg, Inc. | 1991 | — |
| −1 | K070676 | Korebalance (Kinesthetic Ability Trainer) | Sportkat, LLC | 2007 | — |
| 0 (this device) | K121590 | Vestibular Analysis Apparatus | Capacity Sports, LLC | 2012 | — |
| +1 | K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019 | — |
| +1 | K190735 | EQ Balance | Upright Science, Inc. | 2019 | — |
| +1 | K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070676 | Korebalance (Kinesthetic Ability Trainer)Summary page 1…fatigue. The SwayTM Balance System can be used wherever an iOS mobile operating device is available. Predicate Device(s) KorebalanceTM by SPORTKAT, LLC (K070676) Device Description The Sway BalanceTM System is a mobile measurement system that analyzes balance through thoracic sway, using… | 2007 |
What descends from it? (3)
3 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 21 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K183661 (Quadrant Biosciences, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070676.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Sway™ 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 and coaches, physical therapists, nurses and physicians. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121590: Vestibular Analysis Apparatus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121590
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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