510(k) · Cleared
ClearedK-D Balance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
King-Devick Technologies, Inc. · LXV Apparatus, Vestibular Analysis
Cleared on Apr 2, 2018 as substantially equivalent to K121590 (Capacity Sports, LLC, 2012) after a 123-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Apr 2, 2018
- Review
- 123 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 deviceK173669 K-D BalanceKing-Devick Technologies, Inc. · 2018
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) | K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K121590 | Vestibular Analysis ApparatusSummary page 4…Fax: 630-501-0285 Preparation Date October 17, 2017 (revised March 30, 2018) Predicate Device Sway Balance TM by Capacity Sports, LLC (K121590) Device Description K-D Balance is a mobile balance test to be used on the 6th generation iPhone or iPod touch with iOS versions… | 2012 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.5 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. 2018, 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?
K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and…
Read the full statement (141 words)
K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with conditions that could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173669: K-D Balance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173669
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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