510(k) · Cleared

Cleared

Rion Electro-Palatograph Model DP-01

K802870510(k) TraditionalCleared Dec 17, 198033-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kindel & Anderson · LEZ Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

Cleared on Dec 17, 1980 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Dec 17, 1980
Review: 33 days
Class: Class U
Product code: LEZ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK802870 Rion Electro-Palatograph Model DP-01Kindel & Anderson · 1980
Descendant · cites it directly · 1 of its ownK982396 Visivox, Model V-2Rsq, LLC · 1998
Descendant · 2 generations on · 0 of its ownK091682 LSVT C or LSVT Companion, Model V.1Lsvt Global, LLC · 2009

Most influential descendants

Showing 2 of 2 · See all

K982396Visivox, Model V-2Rsq, LLC · 1998 · cites it directly1descendant
K091682LSVT C or LSVT Companion, Model V.1Lsvt Global, LLC · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K802870	Rion Electro-Palatograph Model DP-01	Kindel & Anderson	1980	—
+1	K982396	Visivox, Model V-2	Rsq, LLC	1998	—
+2	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
1998	1	0
2009	1	0

FIG. 1 — Lineage of K802870, 1980–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982396	Visivox, Model V-2	Rsq, LLC	1998	1

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?

Of its descendants, K982396 (Rsq, LLC, 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LEZ devices

LEZ 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

2007high 1 (2009) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K802870 · printed Nov 5, 2026

Cite this page

510(k) Report. “K802870: Rion Electro-Palatograph Model DP-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K802870

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026