510(k) · Cleared
ClearedKorebalance (Kinesthetic Ability Trainer)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sportkat, LLC · LXV Apparatus, Vestibular Analysis
Cleared on Apr 18, 2007 as substantially equivalent to K911795 (Breg, Inc., 1991) after a 37-day review. Its family tree reaches back 1 generation to 1991. 5 later devices descend from it.
- Decided
- Apr 18, 2007
- Review
- 37 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911795 (1991). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911795 Kinesthetic Ability Trainer (K.a.T., Model 1000)Breg, Inc. · 1991
- This deviceK070676 Korebalance (Kinesthetic Ability Trainer)Sportkat, LLC · 2007
- Descendant · cites it directly · 3 of its ownK121590 Vestibular Analysis ApparatusCapacity Sports, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK183661 ClearEdge Balance SystemQuadrant Biosciences · 2019
- Descendant · 2 generations on · 0 of its ownK190735 EQ BalanceUpright Science, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK173669 K-D BalanceKing-Devick Technologies, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK081602 DizzyfixClearwater Clinical Limited · 2008
Most influential descendants
Showing 5 of 5 · See all- K121590Vestibular Analysis ApparatusCapacity Sports, LLC · 2012 · cites it directly3descendants
- K183661ClearEdge Balance SystemQuadrant Biosciences · 2019 · 2 generations on0descendants
- K190735EQ BalanceUpright Science, Inc. · 2019 · 2 generations on0descendants
- K173669K-D BalanceKing-Devick Technologies, Inc. · 2018 · 2 generations on0descendants
- K081602DizzyfixClearwater Clinical Limited · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911795 | Kinesthetic Ability Trainer (K.a.T., Model 1000) | Breg, Inc. | 1991 | — |
| 0 (this device) | K070676 | Korebalance (Kinesthetic Ability Trainer) | Sportkat, LLC | 2007 | — |
| +1 | K121590 | Vestibular Analysis Apparatus | Capacity Sports, LLC | 2012 | — |
| +2 | K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019 | — |
| +2 | K190735 | EQ Balance | Upright Science, Inc. | 2019 | — |
| +2 | K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018 | — |
| +1 | K081602 | Dizzyfix | Clearwater Clinical Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K911795 | Kinesthetic Ability Trainer (K.a.T., Model 1000)Summary page 1…ural Pressure Platform) Classification: Unclassified Product Code: LXV Predicate Device: This Special 5 10k is for changes to the previously cleared K.A.T. 1000 device (K91 1795) Device Description: The updated KorebalanCeTm Kinesthetic Ability Trainer device has the same intended use and incorporates the… | 1991 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K121590 (Capacity Sports, LLC, 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 KorebalanceTM device is intended for use in balance therapy, only by health care professionals with experience in balance therapy. Patient suitability must be judged by the health professional on a case by case basis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070676: Korebalance (Kinesthetic Ability Trainer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070676
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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