510(k) · Cleared
ClearedDizzyfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearwater Clinical Limited · LXV Apparatus, Vestibular Analysis
Cleared on Sep 19, 2008 as substantially equivalent to K071973 (Vesticon, 2008) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Sep 19, 2008
- Review
- 105 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K946229 (1995). 8 ancestors in all, the oldest K863424 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946229 | Balance Manager | Neurocom International, Inc. | 1995 | — |
| −2 | K070085 | Balance Rehabilitation Unit (Bru) | Medicaa (Uruguay) S.A. | 2007 | — |
| −1 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| 0 (this device) | K081602 | Dizzyfix | Clearwater Clinical Limited | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K071973 | Epley Omniax Cleared while this submission was under review Summary page 2…td. - Calgary, Alberta, Canada DizzyFIX - Device for assisting in the Particle Repositioning Maneuver Apparatus, vestibular analysis (LXV) 510(k) Number: K071973 Device Name:EPLEY OMNIAX Applicant:VESTICON 2203 NE Oregon Street Portland, OR 97232 Predicate Device #2 Apparatus, vestibular… | 2008 |
| * | K070676 | Korebalance (Kinesthetic Ability Trainer)Summary page 2…Number: K071973 Device Name:EPLEY OMNIAX Applicant:VESTICON 2203 NE Oregon Street Portland, OR 97232 Predicate Device #2 Apparatus, vestibular analysis 510(k) Number: K070676 Device Name:KOREBALANCE (KINESTHETIC ABILITY TRAINER) Applicant:SPORTKAT, LLC 1497 Poinsettia Ave. Ste. 157 Vista, CA 92083 Pred… | 2007 |
| * | K070085 | Balance Rehabilitation Unit (Bru)Summary page 2…E (KINESTHETIC ABILITY TRAINER) Applicant:SPORTKAT, LLC 1497 Poinsettia Ave. Ste. 157 Vista, CA 92083 Predicate Device #3 Apparatus, vestibular analysis 510(k) Number: K070085 Device Name BALANCE REHABILITATION UNIT (BRU) Applicant:MEDICAA (URUGUAY) S.A. 1101 South Capital Texas Hwy. Suite f254 Austin, T… | 2007 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K071973.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
1. Patients with a diagnosis of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) who exhibit:
a. Momentary spinning dizziness,
b. Which lasts seconds to minutes,
c. Which is associated with position change
Clinical settings
1. Physician offices
2. Hospitals
3. Long Term, Urgent and Emergent care facilities
4. Patient's homes
5. Allied Health and Complementary Health clinics and offices
Target population
1. Adults (age >18)
2. For use by patients or health practitioners
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081602: Dizzyfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081602
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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