510(k) · Cleared
ClearedVisivox, Model V-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rsq, LLC · LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Cleared on Sep 14, 1998 as substantially equivalent to K802870 (Kindel & Anderson, 1980) after a 67-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.
- Decided
- Sep 14, 1998
- Review
- 67 days
- Class
- Class U
- Product code
- LEZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802870 (1980). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K091682LSVT C or LSVT Companion, Model V.1Lsvt Global, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802870 | Rion Electro-Palatograph Model DP-01 | Kindel & Anderson | 1980 | — |
| 0 (this device) | K982396 | Visivox, Model V-2 | Rsq, LLC | 1998 | — |
| +1 | K091682 | LSVT C or LSVT Companion, Model V.1 | Lsvt Global, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 LEZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K802870 | Rion Electro-Palatograph Model DP-01Summary page 2…e name is also VISIVOX. The Common Name is Voice Level Monitor The Device Classification Name is Aids,Speech Training for the Hearing Impaired as shown in 510(k) Number K802870, for the Rion Electro-Palatograph . to which we claim equivalence. 16 Tel(909)626-3172;Fax(909)626-7366 | R RS… | 1980 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091682 | LSVT C or LSVT Companion, Model V.1 | 2009 | 0 |
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, K091682 (Lsvt Global, LLC, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LEZ devicesLEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LEZ
Too few LEZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LEZ
No recall names LEZ since 2007.
Adverse event reports per year · LEZ
No MAUDE report names LEZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To be used as an assistive device and training aid, complementing person-to-person speech therapy:
1.For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech.
2.For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke,Parkinsons’, traumatic head or spine injuries, cleft palate, laryngectomies or other causes.
3.For speech- and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982396 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982396: Visivox, Model V-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982396
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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